Communication capability of a smart stapler

ABSTRACT

A surgical instrument may have multiple operating modes. An instrument operation mode may be selected from multiple operation modes, which may be preconfigured, dynamically updated, semi-dynamically updated, periodically updated, or preset. Multi-modal instrument operation may control the availability, access, level of use, level of interaction and/or support for one or more capabilities available through an instrument. A multi-modal surgical instrument may be fully operational in multiple modes of operation while varying one or more capabilities based on a mode of operation, such as one or more of sensors, communications, user-instrument interaction, displays, data storage, data access, data aggregation, data analytics, surgical support, feedback, surgical recommendations, etc. An instrument may be configured to determine an operation mode based on one or more instrument operation control parameters, such as system capabilities, system capacity parameters, system condition parameters, system authorization parameters, and/or external control parameters.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is related to an application filed contemporaneously,with Attorney Docket No. END9287USNP1, entitled METHOD FOR OPERATINGTIERED OPERATION MODES IN A SURGICAL SYSTEM, the contents of which isincorporated by reference herein.

BACKGROUND

Surgical systems often incorporate an imaging system, which can allowthe clinician(s) to view the surgical site and/or one or more portionsthereof on one or more displays such as a monitor, for example. Thedisplay(s) can be local and/or remote to a surgical theater. An imagingsystem can include a scope with a camera that views the surgical siteand transmits the view to a display that is viewable by a clinician.Scopes include, but are not limited to, arthroscopes, angioscopes,bronchoscopes, choledochoscopes, colonoscopes, cytoscopes,duodenoscopes, enteroscopes, esophagogastro-duodenoscopes(gastroscopes), endoscopes, laryngoscopes, nasopharyngo-neproscopes,sigmoidoscopes, thoracoscopes, ureteroscopes, and exoscopes. Imagingsystems can be limited by the information that they are able torecognize and/or convey to the clinician(s). For example, certainconcealed structures, physical contours, and/or dimensions within athree-dimensional space may be unrecognizable intraoperatively bycertain imaging systems. Additionally, certain imaging systems may beincapable of communicating and/or conveying certain information to theclinician(s) intraoperatively-.

SUMMARY

A surgical instrument, such as a surgical stapler, may have multipleoperating modes, which may provide different combinations ofcommunication, interaction, support and/or other capabilities. Aninstrument operation mode may be selected from multiple operation modes,which may be preconfigured, dynamically updated, semi-dynamicallyupdated, periodically updated, or preset. Multi-modal instrumentoperation may control the availability, access, level of use, level ofinteraction and/or support for one or more capabilities availablethrough an instrument. Instrument operation modes may variously allow orrestrict instrument capabilities. Instrument capabilities authorized bya mode of operation may be variously unlocked, configured, or downloadedand installed. Resident capabilities of a surgical instrument notauthorized by a mode of operation may be unutilized, locked or otherwiseblocked. Instrument capabilities that vary by mode of operation mayinclude, for example, sensors, communications, displays, data storage,data access, data aggregation, data analyses, feedback, recommendations,etc. In some implementations, a multi-modal surgical instrument may befully operational in multiple modes of operation. Modes may vary interms of communication capabilities, such as recordkeeping, data accessand recall, data analyses, surgical recommendations, and so on.

An instrument may be configured to determine an instrument operationmode based on one or more instrument operation control parameters, suchas one or more of the following: system capabilities (e.g., hardwarecapabilities, firmware capabilities and/or software capabilities),system capacity parameters (e.g., a wired and/or wireless connectivitycapability); system condition parameters (e.g., bandwidth, interference,conductivity, current load level); system authorization parameters(e.g., parameters indicating compatibility, authorized (purchased orsubscription) mode of instrument operation, instrument authenticity)and/or external control parameters (e.g., provided by a surgical hub orremote/cloud serer), such as software version, revision or update level,subscription level, interconnectivity with an external/outside system,region of use, user input's), or (e.g., secure) communication with anexternal database system.

Instrument operation mode control parameter(s) may include aconsumer-controlled parameter, such as a subscription level. Forexample, a medical facility may purchase a subscription for selectedinstrument capabilities, which may be grouped into one or more modes ofinstrument operation.

For example, a surgical instrument may determine whether to obtain asensed parameter associated with a sensor signal from a sensor based onthe surgical instrument operation mode. A surgical instrument maydetermine whether to receive an instrument usage instruction based onthe surgical instrument operation mode. The surgical instrument maycommunicate with a surgical hub based on the determination(s).

For example, a surgical instrument may determine, based on theinstrument operation mode, whether to receive recommended instrumentusage information (e.g., stapler cartridge selection) generated based onaggregated historical instrument usage data. A surgical instrument maydetermine, based on the instrument operation mode, whether to receive astapler cartridge selection recommendation generated based on aggregatedcartridge usage data associated with a surgical procedural step. Thesurgical instrument may communicate with a surgical hub based on thedetermination(s).

For example, a remote server may, based on the surgical instrumentoperation mode, receive instrument usage information associated with amedical procedure performed by a surgeon, aggregate the receivedinstrument usage information with historic instrument usage informationassociated with the surgeon, and send the aggregated instruction usageinformation to the surgical instrument (e.g., directly or via a surgicalhub). The remote server may, based on the surgical instrument operationmode, correlate the received instrument usage information to an outcomeof the medical procedure and to an instrument operation status duringthe medical procedure; and send the correlated information to thesurgical instrument (e.g., directly or via a surgical hub). The remoteserver may, based on the surgical instalment operation mode, determine arecommended instrument usage information associated with an upcomingmedical procedure based on the correlated information; and send therecommended instrument usage information to the surgical instrument(e.g., directly or via a surgical hub).

In an example surgical instrument operation mode, a surgical instrumentmay engage in unidirectional communication during operation (e.g.,following initialization, which may support limited bidirectionalcommunication) by sending information (e.g., surgical procedureinformation, such as staple cartridge type and/or ID, errors, instrumentstatus) to a surgical hub. The surgical hub may send the receivedinformation to a remote serves (e.g., a remote processing server and/ora remote database in the cloud).

In an example surgical instrument operation mode, a surgical instrumentmay engage in bidirectional communication by sending information to andreceiving information from a surgical hub, which may send the receivedinformation to a remote server (e.g., a remote processing server and/ora remote database in the cloud). The surgical instrument may receiveinformation (e.g., surgical procedure recommendations) based on theinformation sent to the surgical hub and/or remote server (e.g.,surgical procedure, sensed parameter(s), instrument usage information).The surgical hub and/or remote server may analyze historical informationto render recommendations (e.g., force to fire, wait time, displayinformation on one or more displays).

In an example surgical instrument operation mode, a surgical instrumentmay engage in bidirectional communication by sending information to andreceiving information from a surgical hub. The surgical hub may send thereceived information to a remote server (e.g., a remote processingserver and/or a remote database in the cloud). The surgical instrumentmay receive information (e.g., surgical procedure recommendations) basedon the information sent to the surgical hub and/or remote server (e.g.,surgical procedure, sensed parameter(s), instrument usage information),which may analyze historical information to render recommendations(e.g., force to fire, wait time, display information on one or moredisplays). The surgical instrument may determine, based on a surgicalinstrument operation mode, whether to send various surgical informationto a surgical hub and/or remote server for archiving, subsequentretrieval, data aggregation, analyses and/or recommendations. Thearchived surgical information may be aggregated with historicalinformation by a particular user (e.g., surgeon) and/or informationreceived from other surgical hub(s), and/or surgical informationassociated with other medical facilities. The aggregated information maybe accessed to generate instructional information for one or moresurgical instrument(s). In an example, information aggregated mayinclude information received from smart surgical devices, informationassociated with multiple surgeries, surgical information andcorresponding outcomes associated with multiple patients. The aggregatedinformation may be stored in a remote database. In an example, thesurgical information may be aggregated at a remote server. A surgicalinstrument may determine, for example, based on a surgical instrumentoperation mode, whether to receive historical data, aggregated data,recommendations based on aggregated historical data, etc.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of a computer-implemented interactive surgicalsystem.

FIG. 2 shows an example surgical system being used to perform a surgicalprocedure in an operating room.

FIG. 3 shows an example surgical hub paired with a visualization system,a robotic system, and an intelligent instrument, in accordance with atleast one aspect of the present disclosure.

FIG. 4 illustrates a surgical data network having a communication hubconfigured to connect modular devices located in one or more operatingtheaters of a healthcare facility, or any room in a healthcare facilityspecially equipped for surgical operations, to the cloud, in accordancewith at least one aspect of the present disclosure.

FIG. 5 illustrates an example computer-implemented interactive surgicalsystem.

FIG. 6 illustrates an example surgical hub comprising a plurality ofmodules coupled to the modular control tower.

FIG. 7 shows an example surgical instrument or tool.

FIG. 8 illustrates an example surgical instrument or tool having motorsthat can be activated to performs various functions.

FIG. 9 is a diagram of an example situationally aware surgical system.

FIG. 10 illustrates an example timeline of an illustrative surgicalprocedure and the inferences that the surgical hub can make from thedata detected at each step in the surgical procedure.

FIG. 11 is a block diagram of the computer-implemented interactivesurgical system.

FIG. 12 illustrates the functional architecture of an examplecomputer-implemented interactive surgical system.

FIG. 13 illustrates an example computer-implemented interactive surgicalsystem that is configured to adaptively generate control program updatesfor modular devices.

FIG. 14 illustrates an example surgical system that includes a handlehaving a controller and a motor, an adapter releasably coupled to thehandle, and a loading unit releasably coupled to the adapter.

FIG. 15A illustrates an example flow for determining a mode of operationand operating in the determined mode.

FIG. 15B illustrates an example flow for changing a mode of operation.

FIG. 16 is a perspective view of a powered surgical stapling system.

FIG. 17 is a perspective view of an interchangeable surgical shaftassembly of the powered surgical stapling system of FIG. 16.

FIG. 18 is an exploded assembly view of portions of a handle assembly ofthe powered surgical stapling system of FIG. 16.

FIG. 19 is an exploded assembly view of the interchangeable surgicalshaft assembly of FIG. 17.

FIG. 20 is another partial exploded assembly view of a portion of theinterchangeable surgical shaft assembly of FIG. 19.

FIG. 21 is a perspective view of another powered surgical staplingsystem.

FIG. 22 illustrates an example surgical instrument operation mode.

FIG. 23 illustrates an example surgical instrument operation mode.

FIG. 24 illustrates an example surgical instrument operation mode.

FIG. 25 is a diagram of an illustrative analytics system updating asurgical instrument control program, in accordance with at least oneaspect of the present disclosure.

FIG. 26 is a block diagram of a computer-implemented interactivesurgical system, in accordance with at least one aspect of the presentdisclosure.

FIG. 27 illustrates an example flow for operating in accordance withsurgical instrument operation mode(s).

DETAILED DESCRIPTION

Applicant of the present application owns the following U.S. PatentApplications, each of which is herein incorporated by reference in itsentirety:

-   -   U.S. patent application Ser. No. 15/940,656, entitled “SURGICAL        HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM        DEVICES,” filed on Mar. 29, 2018, now U.S. Patent Application        Publication No. 2019/0201141;    -   U.S. patent application Ser. No. 16/361,793, entitled “SURGICAL        INSTRUMENT COMPRISING AN ADAPTIVE CONTROL SYSTEM,” filed Mar.        22, 2019, now U.S. Patent Application Publication No.        20190314015;    -   U.S. patent application Ser. No. 13/803,086, entitled        “ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION        LOCK,” now U.S. Patent Application Publication No. 2014/0263541;    -   U.S. patent application Ser. No. 13/800,067, entitled “STAPLE        CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM,” filed on Mar. 13,        2013, now U.S. Patent Application Publication No. 2014/0263552;    -   U.S. patent application Ser. No. 16/024,075, entitled “SAFETY        SYSTEMS FOR SMART POWERED SURGICAL STAPLING,” filed on Jun. 29,        2018, now U.S. Patent Application Publication No. 2019/0201146;    -   U.S. patent application Ser. No. 16/182,246, entitled        “ADJUSTMENTS BASED ON AIRBORNE PARTICLE PROPERTIES,” filed on        Nov. 6, 2018, now U.S. Patent Application Publication No.        2019/0204201;    -   U.S. patent application Ser. No. 15/940,679, entitled        “CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS        WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET,”        filed on Mar. 29, 2018, now U.S. Patent Application Publication        No. 2019/0201144;    -   U.S. patent application Ser. No. 15/940,668, entitled        “AGGREGATION AND REPORTING OF SURGICAL HUB DATA,” filed on Mar.        29, 2018, now U.S. Patent Application Publication No.        2019/0201115; and    -   U.S. patent application Ser. No. 16/209,416, now U.S. Patent        Application Publication No. 20190206562.

Referring to FIG. 1, a computer-implemented interactive surgical system100 may include one or more surgical systems 102 and a cloud-basedsystem (e.g., the cloud 104 that may include a remote server 113 coupledto a storage device 105). Each surgical system 102 may include at leastone surgical hub 106 in communication with the cloud 104 that mayinclude a remote server 113. In one example, as illustrated in FIG. 1,the surgical system 102 includes a visualization system 108, a roboticsystem 110, and a handheld intelligent surgical instrument 112, whichare configured to communicate with one another and/or the hub 106. Insome aspects, a surgical system 102 may include an M number of hubs 106,an N number of visualization systems 108, an 0 number of robotic systems110, and a P number of handheld intelligent surgical instruments 112,where M, N, O, and P may be integers greater than or equal to one.

In various aspects, the visualization system 108 may include one or moreimaging sensors, one or more image-processing units, one or more storagearrays, and one or more displays that are strategically arranged withrespect to the sterile field, as illustrated in FIG. 2. In one aspect,the visualization system 108 may include an interface for HL7, PACS, andEMR. Various components of the visualization system 108 are describedunder the heading “Advanced Imaging Acquisition Module” in U.S. PatentApplication Publication No. US 2019-0200844 A1 (U.S. patent applicationSer. No. 16/209,385), tided METHOD OF HUB COMMUNICATION, PROCESSING,STORAGE AND DISPLAY, filed Dec. 4, 2018, the disclosure of which isherein incorporated by reference in its entirety.

As illustrated in FIG. 2, a primary display 119 is positioned in thesterile field to be visible to an operator at the operating table 114.In addition, a visualization tower 111 is positioned outside the sterilefield. The visualization tower 111 may include a first non-steriledisplay 107 and a second non-sterile display 109, which face away fromeach other. The visualization system 108, guided by the hub 106, isconfigured to utilize the displays 107, 109, and 119 to coordinateinformation flow to operators inside and outside the sterile field. Forexample, the hub 106 may cause the visualization system 108 to display asnapshot of a surgical site, as recorded by an imaging device 124, on anon-sterile display 107 or 109, while maintaining a live feed of thesurgical site on the primary display 119. The snapshot on thenon-sterile display 107 or 109 can permit a non-sterile operator toperform a diagnostic step relevant to the surgical procedure, forexample.

In one aspect, the hub 106 may also be configured to route a diagnosticinput or feedback entered by a non-sterile operator at the visualizationtower 111 to the primary display 119 within the sterile field, where itcan be viewed by a sterile operator at the operating table. In oneexample, the input can be in the form of a modification to the snapshotdisplayed on the non-sterile display 107 or 109, which can be routed tothe primary, display 119 by the hub 106.

Referring to FIG. 2, a surgical instrument 112 is being used in thesurgical procedure as part of the surgical system 102. The hub 106 mayalso be configured to coordinate information flow to a display of thesurgical instrument 112. For example, in U.S. Patent ApplicationPublication No. US 2019-0200844 A1 (U.S. patent application Ser. No.16/209,385), titled METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE ANDDISPLAY, filed Dec. 4, 2018, the disclosure of which is hereinincorporated by reference in its entirety. A diagnostic input orfeedback entered by a non-sterile operator at the visualization tower111 can be routed by the hub 106 to the surgical instrument display 115within the sterile field, where it can be viewed by the operator of thesurgical instrument 112. Example surgical instruments that are suitablefor use with the surgical system 102 are described under the heading“Surgical Instrument Hardware” and in U.S. Patent ApplicationPublication No. US 2019-0200844 A1 (U.S. patent application Ser. No.16/209,385), titled METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE ANDDISPLAY, filed Dec. 4, 2018, the disclosure of which is hereinincorporated by reference in its entirety, for example.

FIG. 2 depicts an example of a surgical system 102 being used to performa surgical procedure on a patient who is lying down on an operatingtable 114 in a surgical operating room 116. A robotic system 110 may beused in the surgical procedure as a part of the surgical system 102. Therobotic system 110 may include a surgeon's console 118, a patient sidecart 120 (surgical robot), and a surgical robotic hub 122. The patientside cart 120 can manipulate at least one removably coupled surgicaltool 117 through a minimally invasive incision in the body of thepatient while the surgeon views the surgical site through the surgeon'sconsole 118. An image of the surgical site can be obtained by a medicalimaging device 124, which can be manipulated by the patient side cart120 to orient the imaging device 124. The robotic hub 122 can be used toprocess the images of the surgical site for subsequent display to thesurgeon through the surgeon's console 118.

Other types of robotic systems can be readily adapted for use with thesurgical system 102. Various examples of robotic systems and surgicaltools that are suitable for use with the present disclosure aredescribed in U.S. Patent Application Publication No. US 2019-0201137 A1(U.S. patent application Ser. No. 16/209,407), titled METHOD OF ROBOTICHUB COMMUNICATION, DETECTION, AND CONTROL, filed Dec. 4, 2018, thedisclosure of which is herein incorporated by reference in its entirety.

Various examples of cloud-based analytics that are performed by thecloud 104, and are suitable for use with the present disclosure, aredescribed in U.S. Patent Application Publication No. US 2019-0206569 A1(U.S. patent application Ser. No. 16/209,403), titled METHOD OF CLOUDBASED DATA ANALYTICS FOR USE WITH THE HUB, filed Dec. 4, 2018, thedisclosure of which is herein incorporated by reference in its entirety.

In various aspects, the imaging device 124 may include at least oneimage sensor and one or more optical components. Suitable image sensorsmay include, but are not limited to, Charge-Coupled Device (CCD) sensorsand Complementary Metal-Oxide Semiconductor (CMOS sensors.

The optical components of the imaging device 124 may include one or moreillumination sources and/or one or more lenses. The one or moreillumination sources may be directed to illuminate portions of thesurgical field. The one or more image sensors may receive lightreflected or refracted from the surgical field, including lightreflected or refracted from tissue and/or surgical instruments.

The one or more illumination sources may be configured to radiateelectromagnetic energy in the visible spectrum as well as the invisiblespectrum. The visible spectrum, sometimes referred to as the opticalspectrum or luminous spectrum, is that portion of the electromagneticspectrum that is visible to (i.e., can be detected by) the human eye andmay be referred to as visible light or simply light. A typical human eyewill respond to wavelengths in air that are from about 380 nm to about750 nm.

The invisible spectrum (e.g., the non-luminous spectrum) is that portionof the electromagnetic spectrum that lies below and above the visiblespectrum (i.e., wavelengths below about 380 nm and above about 750 nm).The invisible spectrum is not detectable by the human eye. Wavelengthsgreater than about 750 am are longer than the red visible spectrum, andthey become invisible infrared (IR), microwave, and radioelectromagnetic radiation. Wavelengths less than about 380 nm areshorter than the violet spectrum, and they become invisible ultraviolet,x-ray, and gamma ray electromagnetic radiation.

In various aspects, the imaging device 124 is configured for use in aminimally invasive procedure. Examples of imaging devices suitable foruse with the present disclosure include, but not limited to, anarthroscope, angioscope, bronchoscope, choledochoscope, colonoscope,cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope(gastroscope), endoscope, laryngoscope, nasopharyngo-neproscope,sigmoidoscope, thoracoscope, and ureteroscope.

The imaging device may employ multi-spectrum monitoring to discriminatetopography and underlying structures. A multi-spectral image is one thatcaptures image data within specific wavelength ranges across theelectromagnetic spectrum. The wavelengths may be separated by filters orby the use of instruments that are sensitive to particular wavelengths,including light from frequencies beyond the visible light range, e.g.,IR and ultraviolet. Spectral imaging can allow extraction of additionalinformation the human eye fails to capture with its receptors for red,green, and blue. The use of multi-spectral imaging is described ingreater detail under the heading “Advanced Imaging Acquisition Module”in U.S. Patent Application Publication No. US 2019-0200844 A1 (U.S.patent application Ser. No. 16/209,385), titled METHOD OF HUBCOMMUNICATION, PROCESSING, STORAGE AND DISPLAY, filed Dec. 4, 2018, thedisclosure of which is herein incorporated by reference in its entirety.Multi-spectrum monitoring can be a useful tool in relocating a surgicalfield after a surgical task is completed to perform one or more of thepreviously described tests on the treated tissue. It is axiomatic thatstrict sterilization of the operating room and surgical equipment isrequired during any surgery. The strict hygiene and sterilizationconditions required in a “surgical theater,” i.e., an operating ortreatment room, necessitate the highest possible sterility of allmedical devices and equipment. Part of that sterilization process is theneed to sterilize anything that comes in contact with the patient orpenetrates the sterile field, including the imaging device 124 and itsattachments and components. It will be appreciated that the sterilefield may be considered a specified area, such as within a tray or on asterile towel, that is considered free of microorganisms, or the sterilefield may be considered an area, immediately around a patient, who hasbeen prepared for a surgical procedure. The sterile field may includethe scrubbed team members, who are properly attired, and all furnitureand fixtures in the area.

Referring now to FIG. 3, a hub 106 is depicted in communication with avisualization system 108, a robotic system 110, and a handheldintelligent surgical instrument 112. The hub 106 includes a hub display135, an imaging module 138, a generator module 140, a communicationmodule 130, a processor module 132, a storage array 134, and anoperating-room mapping module 133. In certain aspects, as illustrated inFIG. 3, the hub 106 further includes a smoke evacuation module 126and/or a suction; irrigation module 128. During a surgical procedure,energy application to tissue, for sealing and/or cutting, is generallyassociated with smoke evacuation, suction of excess fluid, and/orirrigation of the tissue. Fluid, power, and/or data lines from differentsources are often entangled during the surgical procedure. Valuable timecan be lost addressing this issue during a surgical procedure.Detangling the lines may necessitate disconnecting the lines from theirrespective modules, which may require resetting the modules. The hubmodular enclosure 136 offers a unified environment for managing thepower, data, and fluid lines, which reduces the frequency ofentanglement between such lines. Aspects of the present disclosurepresent a surgical hub for use in a surgical procedure that involvesenergy application to tissue at a surgical site. The surgical hubincludes a hub enclosure and a combo generator module slidablyreceivable in a docking station of the hub enclosure. The dockingstation includes data and power contacts. The combo generator moduleincludes two or more of an ultrasonic energy generator component, abipolar RF energy generator component, and a monopolar RF energygenerator component that are housed in a single unit. In one aspect, thecombo generator module also includes a smoke evacuation component, atleast one energy delivery cable for connecting the combo generatormodule to a surgical instrument, at least one smoke evacuation componentconfigured to evacuate smoke, fluid, and/or particulates generated bythe application of therapeutic energy to the tissue, and a fluid lineextending from the remote surgical site to the smoke evacuationcomponent. In one aspect, the fluid line is a first fluid line and asecond fluid line extends from the remote surgical site to a suction andirrigation module slidably received in the hub enclosure. In one aspect,the hub enclosure comprises a fluid interface. Certain surgicalprocedures may require the application of more than one energy type tothe tissue. One energy type may be more beneficial for cutting thetissue, while another different energy type may be more beneficial forsealing the tissue. For example, a bipolar generator can be used to sealthe tissue while an ultrasonic generator can be used to cut the sealedtissue. Aspects of the present disclosure present a solution where a hubmodular enclosure 136 is configured to accommodate different generators,and facilitate an interactive communication therebetween. One of theadvantages of the hub modular enclosure 136 is enabling the quickremoval and/or replacement of various modules. Aspects of the presentdisclosure present a modular surgical enclosure for use in a surgicalprocedure that involves energy application to tissue. The modularsurgical enclosure includes a first energy-generator module, configuredto generate a first energy for application to the tissue, and a firstdocking station comprising a first docking port that includes first dataand power contacts, wherein the first energy-generator module isslidably movable into an electrical engagement with the power and datacontacts and wherein the first energy-generator module is slidablymovable out of the electrical engagement with the first power and datacontacts. Further to the above, the modular surgical enclosure alsoincludes a second energy-generator module configured to generate asecond energy, different than the first energy, for application to thetissue, and a second docking station comprising a second docking portthat includes second data and power contacts, wherein the secondenergy-generator module is slidably movable into an electricalengagement with the power and data contacts, and wherein the secondenergy-generator module is slidably movable out of the electricalengagement with the second power and data contacts. In addition, themodular surgical enclosure also includes a communication bus between thefirst docking port and the second docking port, configured to facilitatecommunication between the first energy-generator module and the secondenergy-generator module. Referring to FIG. 3, aspects of the presentdisclosure are presented for a hub modular enclosure 136 that allows themodular integration of a generator module 140, a smoke evacuation module126, and a suction/irrigation module 128. The hub modular enclosure 136further facilitates interactive communication between the modules 140,126, 128. The generator module 140 can be a generator module withintegrated monopolar, bipolar, and ultrasonic components supported in asingle housing unit slidably insertable into the hub modular enclosure136. The generator module 140 can be configured to connect to amonopolar device 142, a bipolar device 144, and an ultrasonic device146. Alternatively, the generator module 140 may comprise a series ofmonopolar, bipolar, and/or ultrasonic generator modules that interactthrough the hub modular enclosure 136. The hub modular enclosure 136 canbe configured to facilitate the insertion of multiple generators andinteractive communication between the generators docked into the hubmodular enclosure 136 so that the generators would act as a singlegenerator.

FIG. 4 illustrates a surgical data network 201 comprising a modularcommunication hub 203 configured to connect modular devices located inone or more operating theaters of a healthcare facility, or any room ina healthcare facility specially equipped for surgical operations, to aloud-based system (e.g., the loud 204 that may include a remote server213 coupled to a storage device 205). In one aspect, the modularcommunication hub 203 comprises a network hub 207 and/or a networkswitch 209 in communication with a network router. The modularcommunication hub 203 also can be coupled to a local computer system 210to provide local computer processing and data manipulation. The surgicaldata network 201 may be configured as passive, intelligent, orswitching. A passive surgical data network selves as a conduit for thedata, enabling it to go from one device (or segment) to another and tothe cloud computing resources. An intelligent surgical data networkincludes additional features to enable the traffic passing through thesurgical data network to be monitored and to configure each port in thenetwork hub 207 or network switch 209. An intelligent surgical datanetwork may be referred to as a manageable hub or switch. A switchinghub reads the destination address of each packet and then forwards thepacket to the correct port.

Modular devices 1 a-1 n located in the operating theater may be coupledto the modular communication hub 203. The network hub 207 and/or thenetwork switch 209 may be coupled to a network router 211 to connect thedevices 1 a-1 n to the cloud 204 or the local computer system 210. Dataassociated with the devices 1 a-1 n may be transferred to cloud-basedcomputers via the router for remote data processing and manipulation.Data associated with the devices 1 a-1 n may also be transferred to thelocal computer system 210 for local data processing and manipulation.Modular devices 2 a-2 m located in the same operating theater also maybe coupled to a network switch 209. The network switch 209 may becoupled to the network hub 207 and/or the network router 211 to connectto the devices 2 a-2 m to the cloud 204. Data associated with thedevices 2 a-2 n may be transferred to the cloud 204 via the networkrouter 211 for data processing and manipulation. Data associated withthe devices 2 a-2 m may also be transferred to the local computer system210 for local data processing and manipulation.

It will be appreciated that the surgical data network 201 may beexpanded by interconnecting multiple network hubs 207 and/or multiplenetwork switches 209 with multiple network routers 211. The modularcommunication hub 203 may be contained in a modular control towerconfigured to receive multiple devices 1 a-1 n/2 a-2 m. The localcomputer system 210 also may be contained in a modular control tower.The modular communication hub 203 is connected to a display 212 todisplay images obtained by some of the devices 1 a-1 n/2 a-2 m, forexample during surgical procedures. In various aspects, the devices 1a-1 n/2 a-2 m may include, for example, various modules such as animaging module 138 coupled to an endoscope, a generator module 140coupled to an energy-based surgical device, a smoke evacuation module126, a suction/irrigation module 128, a communication module 130, aprocessor module 132, a storage array 134, a surgical device coupled toa display, and/or a non-contact sensor module, among other modulardevices that may be connected to the modular communication hub 203 ofthe surgical data network 201.

In one aspect, the surgical data network 201 may comprise a combinationof network hub(s), network switches), and network router(s) connectingthe devices 1 a-1 n/2 a-2 m to the cloud. Any one of or all of thedevices 1 a-1 n/2 a-2 m coupled to the network hub or network switch maycollect data in real time and transfer the data to cloud computers fordata processing and manipulation. It will be appreciated that cloudcomputing relies on sharing computing resources rather than having localservers or personal devices to handle software applications. The word“cloud” may be used as a metaphor for “the Internet,” although the termis not limited as such. Accordingly, the term “cloud computing” may beused herein to refer to “a type of Internet-based computing,” wheredifferent services-such as servers, storage, and applications—aredelivered to the modular communication hub 203 and/or computer system210 located in the surgical theater (e.g., a famed, mobile, temporary,or field operating room or space) and to devices connected to themodular communication hub 203 and/or computer system 210 through theInternet. The cloud infrastructure may be maintained by a cloud serviceprovides. In this context, the cloud service provider may be the entitythat coordinates the usage and control of the devices 1 a-1 n/2 a-2 mlocated in one or more operating theaters. The cloud computing servicescan perform a large number of calculations based on the data gathered bysmart surgical instruments, robots, and other computerized deviceslocated in the operating theater. The hub hardware enables multipledevices or connections to be connected to a computer that communicateswith the cloud computing resources and storage.

Applying cloud computer data processing techniques on the data collectedby the devices 1 a-1 n/2 a-2 m, the surgical data network can provideimproved surgical outcomes, reduced costs, and improved patientsatisfaction. At least some of the devices 1 a-1 n/2 a-2 m may beemployed to view tissue states to assess leaks or perfusion of sealedtissue after a tissue seal ng and cutting procedure. At least some ofthe devices 1 a-1 n/2 a-2 m may be employed to identify pathology, suchas the effects of diseases, using the cloud-based computing to examinedata including images of samples of body tissue for diagnostic purposes.This may include localization and margin confirmation of tissue andphenotypes. At least some of the devices 1 a-1 n/2 a-2 m may be employedto identify anatomical structures of the body using a variety of sensorsintegrated with imaging devices and techniques such as overlaying imagescaptured by multiple imaging devices. The data gathered by the devices 1a-1 n/2 a-2 m, including image data, may be transferred to the cloud 204or the local computer system 210 or both for data processing andmanipulation including image processing and manipulation. The data maybe analyzed to improve surgical procedure outcomes by determining iffurther treatment, such as the application of endoscopic intervention,emerging technologies, a targeted radiation, targeted intervention, andprecise robotics to tissue-specific sites and conditions, may bepursued. Such data analysis may further employ outcome analyticsprocessing, and using standardized approaches may provide beneficialfeedback to either confirm surgical treatments and the behavior of thesurgeon or suggest modifications to surgical treatments and the behaviorof the surgeon.

The operating theater devices 1 a-1 n may be connected to the modularcommunication hub 203 over a wired channel or a wifeless channeldepending on the configuration of the devices 1 a-1 n to a network hub.The network hub 207 may be implemented, in one aspect, as a localnetwork broadcast device that works on the physical layer of the OpenSystem Interconnection (OSI) model. The network hub may provideconnectivity to the devices 1 a-1 n located in the same operatingtheater network. The network hub 207 may collect data in the form ofpackets and sends them to the router in half duplex mode. The networkhub 207 may not store any media access control/Internet Protocol(MAC/IP) to transfer the device data. Only one of the devices 1 a-1 ncan send data at a time through the network hub 207. The network hub 207may not have routing tables or intelligence regarding where to sendinformation and broadcasts all network data across each connection andto a remote server 213 (FIG. 4) over the cloud 204. The network hub 207can detect basic network errors such as collisions, but having allinformation broadcast to multiple ports can be a security risk and causebottlenecks.

The operating theater devices 2 a-2 m may be connected to a networkswitch 209 over a wired channel or a wireless channel. The networkswitch 209 works in the data link layer of the OSI model. The networkswitch 209 may be a multicast device for connecting the devices 2 a-2 mlocated in the same operating theater to the network. The network switch209 may send data in the form of frames to the network router 211 andworks in full duplex mode. Multiple devices 2 a-2 m can send data at thesame time through the network switch 209. The network switch 209 storesand uses MAC addresses of the devices 2 a-2 m to transfer data.

The network hub 207 and/or the network switch 209 may be coupled to thenetwork router 211 for connection to the cloud 204. The network router211 works in the network Leer of the OSI model. The network router 211creates a route for transmitting data packets received from the networkhub 207 and/or network switch 211 to cloud-based computer resources forfurther processing and manipulation of the data collected by any one ofor all the devices 1 a-1 n/2 a-2 m. The network router 211 may beemployed to connect two or more different networks located in differentlocations, such as, for example, different operating theaters of thesame healthcare facility or different networks located in differentoperating theaters of different healthcare facilities. The networkrouter 211 may send data in the form of packets to the cloud 204 andworks in full duplex mode. Multiple devices can send data at the sametime. The network router 211 uses IP addresses to transfer data.

In an example, the network hub 207 may be implemented as a USB hub,which allows multiple USB devices to be connected to a host computer.The USB hub may expand a single USB port into several tiers so thatthere are more ports available to connect devices to the host systemcomputer. The network hub 207 may include wired or wireless capabilitiesto receive information over a wired channel or a wireless channel. Inone aspect, a wireless USB short-range, high-bandwidth wireless radiocommunication protocol may be employed for communication between thedevices 1 a-1 n and devices 2 a-2 m located in the operating theater.

In examples, the operating theater devices 1 a-1 n; 2 a-2 m maycommunicate to the modular communication hub 203 via Bluetooth wirelesstechnology standard for exchanging data over short distances (usingshort-wavelength UHF radio waves in the ISM band from 2.4 to 2.485 GHz)from fixed and mobile devices and building personal area networks(PANs). The operating theater devices 1 a-1 n/2 a-2 m may communicate tothe modular communication hub 203 via a number of wireless or wiredcommunication standards or protocols, including but not limited to Wi-Fi(IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, new radio(NR), long-term evolution (LTE), and Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE,GSM, GPRS, CDMA, TDMA, DECT, and Ethernet derivatives thereof, as wellas any other wireless and wired protocols that are designated as 3G, 4G,5G, and beyond. The computing module may include a plurality ofcommunication modules. For instance, a first communication module may bededicated to shorter-range wireless communications such as Wi-Fi andBluetooth, and a second communication module may be dedicated tolonger-range wireless communications such as GPS, EDGE, GPRS, CDMA,WiMAX, LTE, Ev-DO, and others.

The modular communication hub 203 may serve as a central connection forone or all of the operating theater devices 1 a-1 n/2 a-2 m and mayhandle a data type known as frames. Frames may carry the data generatedby the devices 1 a-1 n/2 a-2 m. When a frame is received by the modularcommunication hub 203, it is amplified and transmitted to the networkrouter 211, which transfers the data to the cloud computing resources byusing a number of wireless or wired communication standards orprotocols, as described herein.

The modular communication hub 203 can be used as a standalone device orbe connected to compatible network hubs and network switches to form alarger network. The modular communication hub 203 can be generally easyto install, configure, and maintain, making it a good option fornetworking the operating theater devices 1 a-1 n/2 a-2 m.

FIG. 5 illustrates a computer-implemented interactive surgical system200. The computer-implemented interactive surgical system 200 is similarin many respects to the computer-implemented interactive surgical system100. For example, the computer-implemented interactive surgical system200 includes one or more surgical systems 202, which are similar in manyrespects to the surgical systems 102. Each surgical system 202 includesat least one surgical hub 206 in communication with a cloud 204 that mayinclude a remote sewer 213. In one aspect, the computer-implementedinteractive surgical system 200 comprises a modular control tower 236connected to multiple operating theater devices such as, for example,intelligent surgical instruments, robots, and other computerized deviceslocated in the operating theater. As shown in FIG. 6, the modularcontrol tower 236 comprises a modular communication hub 203 coupled to acomputer system 210.

As illustrated in the example of FIG. 5, the modular control tower 236may be coupled to an imaging module 238 that may be coupled to anendoscope 239, a generator module 240 that may be coupled to an energydevice 241, a smoke evacuator module 226, a suction/irrigation module228, a communication module 230, a processor module 232, a storage array234, a smart device/instrument 235 optionally coupled to a display 237,and a non-contact sensor module 242. The operating theater devices maybe coupled to cloud computing resources and data storage via the modularcontrol tower 236. A robot hub 222 also may be connected to the modularcontrol tower 236 and to the loud computing resources. Thedevices/instruments 235, visualization systems 208, among others, may becoupled to the modular control tower 236 via wired or wirelesscommunication standards or protocols, as described herein. The modularcontrol tower 236 may be coupled to a hub display 215 (e.g., monitor,screen) to display and overlay images received from the imaging module,device/instrument display, and/or other visualization systems 208. Thehub display also may display data received from devices connected to themodular control tower in conjunction with images and overlaid images.

FIG. 6 illustrates a surgical hub 206 comprising a plurality of modulescoupled to the modular control tower 236. The modular control Dower 236may comprise a modular communication hub 203, e.g., a networkconnectivity device, and a computer system 210 to provide localprocessing, visualization, and imaging, for example. As shown in FIG. 6,the modular communication hub 203 may be connected in a tieredconfiguration to expand the number of modules (e.g., devices) that maybe connected to the modular communication hub 203 and transfer dataassociated with the modules to the computer system 210, cloud computingresources, or both. As shown in FIG. 6, each of the networkhubs/switches in the modular communication hub 203 may include threedownstream ports and one upstream port. The upstream network hub/switchmay be connected to a processor to provide a communication connection tothe cloud computing resources and a local display 217. Communication tothe cloud 204 may be made either through a wired or a wirelesscommunication channel.

The surgical hub 206 may employ a non-contact sensor module 242 tomeasure the dimensions of the operating theater and generate a map ofthe surgical theater using either ultrasonic or laser-type non-contactmeasurement devices. An ultrasound-based non-contact sensor module mayscan the operating theater by transmitting a burst of ultrasound andreceiving the echo when it bounces off the perimeter walls of anoperating theater as described under the heading “Surgical Hub SpatialAwareness Within an Operating Room” in U.S. Patent ApplicationPublication No. US 2019-0200844 A1 (U.S. patent application Ser. No.16/209,385), titled METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE ANDDISPLAY, filed Dec. 4, 2018, which is herein incorporated by referencein its entirety, in which the sensor module is configured to determinethe size of the operating theater and to adjust Bluetooth-pairingdistance limits. A laser-based non-contact sensor module may scan theoperating theater by transmitting laser light pulses, receiving laserlight pulses that bounce off the perimeter walls of the operatingtheater, and comparing the phase of the transmitted pulse to thereceived pulse to determine the size of the operating theater and toadjust Bluetooth pairing distance limits, for example.

The computer system 210 may comprise a processor 244 and a networkinterface 245. The processor 244 can be coupled to a communicationmodule 247, storage 248, memory 249, non-volatile memory 250, andinput/output interface 251 via a system bus. The system bus can be anyof several types of bus structure(s) including the memory bus or memorycontroller, a peripheral bus or external bus, and/or a local bus usingany variety of available bus architectures including, but not limitedto, 9-bit bus, Industrial Standard Architecture (ISA), Micro-CharmelArchitecture (MSA), Extended ISA (EISA), Intelligent Drive Electronics(IDE), VESA Local Bus (VLB), Peripheral Component Interconnect (ICI),USB, Advanced Graphics Port (AGP), Personal Computer Memory CardInternational Association bus (PCMCIA), Small Computer Systems Interface(SCSI), or any other proprietary bus.

The processor 244 may be any single-core or multicore processor such asthose known under the trade name ARM Cortex by Texas Instruments. In oneaspect, the processor may be an LM4F230H5QR ARM Cortex-M4F ProcessorCore, available from Texas Instruments, for example, comprising anon-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), an internal read-only memory (ROM) loaded withStellarisWare® software, a 2 KB electrically erasable programmableread-only memory (EEPROM), and/or one or more pulse width modulation(PWM) modules, one or more quadrature encoder inputs (QEI) analogs, oneor more 12-bit analog-to-digital converters (ADCs) with 12 analog inputchannels, details of which are available for the product datasheet.

In one aspect, the processor 244 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The system memory may include volatile memory and non-volatile memory.The basic input/output system (BIOS), containing the basic routines totransfer information between elements within the computer system, suchas during startup, is stored in non-volatile memory. For example, thenon-volatile memory can include ROM, programmable ROM (PROM),electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatilememory includes random-access memory (RAM), which acts as external cachememory. Moreover, RAM is available in many forms such as SRAM, dynamicRAM (PRAM, synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM),enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and direct Rambus RAM(DRRAM).

The computer system 210 also may include removable/non-removable,volatile/non-volatile computer storage media, such as for example diskstorage. The disk storage can include, but is not limited to, deviceslike a magnetic disk drive, floppy disk drive, tape drive, Jaz drive,Zip drive, LS-60 drive, flash memory card, or memory stick. In addition,the disk storage can include storage media separately or in combinationwith other storage media including, but not limited to, an optical discdrive such as a compact disc ROM device (CD-ROM), compact discrecordable drive (CD-R Drive), compact disc rewritable drive (CD-RWDrive), or a digital versatile disc ROM drive (DVD-ROM). To facilitatethe connection of the disk storage devices to the system bus, aremovable or non-removable interface may be employed.

It is to be appreciated that the computer system 210 may includesoftware that acts as an intermediary between users and the basiccomputer resources described in a suitable operating environment. Suchsoftware may include an operating system. The operating system, whichcan be stored on the disk storage, may act to control and allocateresources of the computer system. System applications may take advantageof the management of resources by the operating system through programmodules and program data stored either in the system memory or on thedisk storage. It is to be appreciated that various components describedherein can be implemented with various operating systems or combinationsof operating systems.

A user may enter commands or information into the computer system 210through input device(s) coupled to the I/O interface 251. The inputdevices may include, but are not limited to, a pointing device such as amouse, trackball, stylus, touch pad, keyboard, microphone, joystick,game pad, satellite dish, scanner, TV tuner card, digital camera,digital video camera, web camera, and the like. These and other inputdevices connect to the processor through the system bus via interfaceport(s). The interface port(s) include, for example, a serial port, aparallel port, a game port, and a USB. The output device(s) use some ofthe same types of ports as input device(s). Thus, for example, a USBport may be used to provide input to the computer system and to outputinformation from the computer system to an output device. An outputadapter may be provided to illustrate that there can be some outputdevices like monitors, displays, speakers, and printers, among otheroutput devices that may require special adapters. The output adaptersmay include, by way of illustration and not limitation, video and soundcards that provide a means of connection between the output device andthe system bus. It should be noted that other devices and/or systems ofdevices, such as remote computer(s), may provide both input and outputcapabilities.

The computer system 210 can operate in a networked environment usinglogical connections to one or more remote computers, such as cloudcomputer(s), or local computers. The remote cloud computer(s) can be apersonal computer, sewer, router, network PC, workstation,microprocessor-based appliance, peer device, or other common networknode, and the like, and typically includes many or all of the elementsdescribed relative to the computer system. For purposes of brevity, onlya memory storage device is illustrated with the remote computer(s). Theremote computer(s) may be logically connected to the computer systemthrough a network interface and then physically connected via acommunication connection. The network interface may encompasscommunication networks such as local area networks (LANs) and wide areanetworks (WANs). LAN technologies may include Fiber Distributed DataInterface (FDDI), Copper Distributed Data Interface (CDDI),Ethernet/IEEE 802.3, Token Ring/IEEE 802.5 and the like. WANtechnologies may include, but are not limited to, point-to-point links,circuit-switching networks like Integrated Services Digital Networks(ISDN) and variations thereon, packet-switching networks, and DigitalSubscriber Lines (DSL.

In various aspects, the computer system 210 of FIG. 6, the imagingmodule 238 and/or visualization system 208, and/or the processor module232 of FIGS. 5-6, may comprise an image processor, image-processingengine, media processor, or any specialized digital signal processor(DSP) used for the processing of digital images. The image processor mayemploy parallel computing with single instruction, multiple data (Snip)or multiple instruction, multiple data (MIMD) technologies to increasespeed and efficiency. The digital image-processing engine can perform arange of tasks. The image processor may be a system on a chip withmulticore processor architecture.

The communication connection(s) may refer to the hardware/softwareemployed to connect the network interface to the bus. While thecommunication connection is shown for illustrative clarity inside thecomputer system, it can also be external to the computer system 210. Thehardware; software necessary for connection to the network interface mayinclude, for illustrative purposes only, internal and externaltechnologies such as modems, including regular telephone-grade modems,cable modems, and DSL moderns, ISDN adapters, and Ethernet cards.

FIG. 7 illustrates a logic diagram of a control system 470 of a surgicalinstrument or tool in accordance with one or more aspects of the presentdisclosure. The system 470 may comprise a control circuit. The controlcircuit may include a microcontroller 461 comprising a processor 462 anda memory 468. One or more of sensors 472, 474, 476, for example, providereal-time feedback to the processor 462. A motor 482, driven by a motordriver 492, operably couples a longitudinally movable displacementmember to drive the I-beam knife element. A tracking system 480 may beconfigured to determine the position of the longitudinally movabledisplacement member. The position information may be provided to theprocessor 462, which can be programmed or configured to determine theposition of the longitudinally movable drive member as well as theposition of a firing member, firing bar, and I-bean knife element.Additional motors may be provided at the tool driver interface tocontrol I-beam firing, closure tube travel, shaft rotation, andarticulation. A display 473 may display a variety of operatingconditions of the instruments and may include touch screen functionalityfor data input. Information displayed on the display 473 may be overlaidwith images acquired via endoscopic imaging modules.

In one aspect, the microcontroller 461 may be any single-core ormulticore processor such as those known under the trade name ARM Cortexby Texas Instruments. In one aspect, the main microcontroller 461 may bean LM4F230H5QR ARM Cortex-M4F Processor Core, available from TexasInstruments, for example, comprising an on-chip memory of 256 KBsingle-cycle flash memory, or other non-volatile memory, up to 40 MHz, aprefetch buffer to improve performance above 40 MHz, a 32 KBjingle-cycle SRAM, and internal ROM loaded with StellarisWare® software,a 2 KB EEPROM, one or more P M modules, one or more QEI analogs, and/orone or more 12-bit ADCs with 12 analog input channels, details of whichare available for the product datasheet.

In one aspect, the microcontroller 461 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The microcontroller 461 may be programmed to perform various functionssuch as precise control over the speed and position of the knife andarticulation systems. In one aspect, the microcontroller 461 may includea processor 462 and a memory 468. The electric motor 482 may be abrushed direct current (DC) motor with a gearbox and mechanical links toan articulation or knife system. In one aspect, a motor driver 492 maybe an A3941 available from Allegro Microsystems, Inc. Other motordrivers may be readily substituted for use in the tracking system 480comprising an absolute positioning system. A detailed description of anabsolute positioning system is described in U.S. Patent ApplicationPublication No. 2017/0296213, titled SYSTEMS AND METHODS FOR CONTROLLINGA SURGICAL STAPLING AND CUTTING INSTRUMENT, which published on Oct. 19,2017, which is herein incorporated by reference in its entirety.

The microcontroller 461 may be programmed to provide precise controlover the speed and position of displacement members and articulationsystems. The microcontroller 461 may be configured to compute a responsein the software of the microcontroller 461. The computed response may becompared to a measured response of the actual system to obtain an“observed” response, which is used for actual feedback decisions. Theobserved response may be a favorable, tuned value that balances thesmooth, continuous nature of the simulated response with the measuredresponse, which can detect outside influences on the system.

In some examples, the motor 482 may be controlled by the motor driver492 and can be employed by the firing system of the surgical instrumentor tool. In various forms, the motor 482 may be a brushed DC drivingmotor having a maximum rotational speed of approximately 25,000 RPM. Insome examples, the motor 482 may include a brushless motor, a cordlessmotor, a synchronous motor, a stepper motor, or any other suitableelectric motor. The motor driver 492 may comprise an H-bridge drivercomprising field-effect transistors (FETs), for example. The motor 482can be powered by a power assembly releasable mounted to the handleassembly or tool housing for supplying control power to the surgicalinstrument or tool. The power assembly may comprise a battery which mayinclude a number of battery cells connected in series that can be usedas the power source to power the surgical instrument or tool. In certaincircumstances, the battery cells of the power assembly may bereplaceable and/or rechargeable. In at least one example, the batterycells can be lithium-ion batteries which can be couplable to andseparable from the power assembly.

The motor driver 492 may be an A3941 available from AllegroMicrosystems, Inc. The A3941 492 may be a full-bridge controller for usewith external N-channel power metal-oxide semiconductor field-effecttransistors (MOSFETs) specifically designed for inductive loads, such asbrush DC motors. The driver 492 may comprise a unique charge pumpregulator that can provide full (>10 V) gate drive for battery voltagesdown to 7 V and can allow the A3941 to operate with a reduced gatedrive, down to 5.5 V. A bootstrap capacitor may be employed to providethe above battery supply voltage required for N-channel MOSFETs. Aninternal charge pump for the high-side drive may allow DC (100% dutycycle) operation. The full bridge can be driven in fast or slow decaymodes using diode or synchronous rectification. In the slow decay mode,current recirculation can be through the high-side or the lowside FETs.The power FETs may be protected from shoot-through byresistor-adjustable dead time. Integrated diagnostics provideindications of undervoltage, overtemperature, and power bridge faultsand can be configured to protect the power MOSFETs under most shortcircuit conditions. Other motor drivers may be readily substituted foruse in the tracking system 480 comprising an absolute positioningsystem.

The tracking system 480 may comprise a controlled motor drive circuitarrangement comprising a position sensor 472 according to one aspect ofthis disclosure. The position sensor 472 for an absolute positioningsystem may provide a unique position signal corresponding to thelocation of a displacement member. In some examples, the displacementmember may represent a longitudinally movable drive member comprising arack of drive teeth for meshing engagement with a corresponding drivegear of a gear reducer assembly. In some examples, the displacementmember may represent the firing member, which could be adapted andconfigured to include a rack of drive teeth. In some examples, thedisplacement member may represent a firing bar or the I-beam, each ofwhich can be adapted and configured to include a rack of drive teeth.Accordingly, as used herein, the term displacement member can be usedgenerically to refer to any movable member of the surgical instrument ortool such as the drive member, the firing member, the firing bar, theI-beam, or any element that can be displaced. In one aspect, thelongitudinally movable drive member can be coupled to the firing member,the firing bar, and the I-beam. Accordingly, the absolute positioningsystem can, in effect, track the linear displacement of the I-beam bytracking the linear displacement of the longitudinally movable drivemember. In various aspects, the displacement member may be coupled toany position sensor 472 suitable for measuring linear displacement.Thus, the longitudinally movable drive member, the firing member, thefiring bar, or the I-beam, or combinations thereof, may be coupled toany suitable linear displacement sensor. Linear displacement sensors mayinclude contact or non-contact displacement sensors. Linear displacementsensors may comprise linear variable differential transformers (LVDT),differential variable reluctance transducers (DVRT), a slidepotentiometer, a magnetic sensing system comprising a movable magnet anda series of linearly arranged Hall effect sensors, a magnetic sensingsystem comprising a fixed magnet and a series of movable, linearlyarranged Hall effect sensors, an optical sensing system comprising amovable light source and a series of linearly arranged photo diodes orphoto detectors, an optical sensing system comprising a fixed lightsource and a series of movable linearly, arranged photo diodes or photodetectors, or any combination thereof.

The electric motor 482 can include a rotatable shaft that operablyinterfaces with a gear assembly that is mounted in meshing engagementwith a set, or rack, of drive teeth on the displacement member. A sensorelement may be operably coupled to a gear assembly such that a singlerevolution of the position sensor 472 element corresponds to some linearlongitudinal translation of the displacement member. An arrangement ofgearing and sensors can be connected to the linear actuator, via a rackand pinion arrangement, or a rotary actuator, via a spur gear or otherconnection. A power source may supplied power to the absolutepositioning system and an output indicator may display the output of theabsolute positioning system. The displacement member may represent thelongitudinally movable drive member comprising a rack of drive teethformed thereon for meshing engagement with a corresponding drive gear ofthe gear reducer assembly. The displacement member may represent thelongitudinally movable firing member, firing bar, I-beam, orcombinations thereof.

A single revolution of the sensor element associated with the positionsensor 472 may be equivalent to a longitudinal linear displacement d1 ofthe of the displacement member, where d1 is the longitudinal lineardistance that the displacement member moves from point “a” to point “b”after a single revolution of the sensor element coupled to thedisplacement member. The sensor arrangement may be connected via a gearreduction that results in the position sensor 472 completing one or morerevolutions for the full stroke of the displacement member. The positionsensor 472 may complete multiple revolutions for the full stroke of thedisplacement member.

A series of switches, where n is an integer greater than one, may beemployed alone or in combination with a gear reduction to provide aunique position signal for more than one revolution of the positionsensor 472. The state of the switches may be fed back to themicrocontroller 461 that applies logic to determine a unique positionsignal corresponding to the longitudinal linear displacement d1+d2+ . .. dn of the displacement member. The output of the position sensor 472is provided to the microcontroller 461. The position sensor 472 of thesensor arrangement may comprise a magnetic sensor, an analog rotarysensor like a potentiometer, or an array of analog Hall-effect elements,which output a unique combination of position signals or values.

The position sensor 472 may comprise any number of magnetic sensingelements, such as, for example, magnetic sensors classified according towhether they measure the total magnetic field or the vector componentsof the magnetic field. The techniques used to produce both types ofmagnetic sensors may encompass many aspects of physics and electronics.The technologies used for magnetic field sensing may include searchcoil, fluxgate, optically pumped, nuclear precession, SQUID,Hall-effect, anisotropic magnetoresistance, giant magnetoresistance,magnetic tunnel junctions, giant magnetoimpedance,magnetostrictive/piezoelectric composites, magnetodiode,magnetotransistor, fiber-optic, magneto-optic, andmicroelectromechanical systems-based magnetic sensors, among others.

In one aspect, the position sensor 472 for the tracking system 480comprising an absolute positioning system may comprise a magnetic rotaryabsolute positioning system. The position sensor 472 may be implementedas an AS5055EQFT single-chip magnetic rotary position sensor availablefrom Austria Microsystems, AG. The position sensor 472 is interfacedwith the microcontroller 461 to provide an absolute positioning system.The position sensor 472 may be a low-voltage and low-power component andincludes four Hall-effect elements in an area of the position sensor 472that may be located above a magnet. A high-resolution ADC and a smartpower management controller may also be provided on the chip. Acoordinate rotation digital computer (CORDIC) processor, also known asthe digit-by-digit method and Volder's algorithm, may be provided toimplement a simple and efficient algorithm to calculate hyperbolic andtrigonometric functions that require only addition, subtraction,bitshift, and table lookup operations. The angle position, alarm bits,and magnetic field information may be transmitted over a standard serialcommunication interface, such as a serial peripheral interface (SPI)interface, to the microcontroller 461. The position sensor 472 mayprovide 12 or 14 bits of resolution. The position sensor 472 may be anAS5055 chip provided in a small QFN 16-pin 4×4×0.85 mm package.

The tracking system 480 comprising an absolute positioning system maycomprise and/or be programmed to implement a feedback controller, suchas a PID, state feedback, and adaptive controller. A power sourceconverts the signal from the feedback controller into a physical inputto the system: in this case the voltage. Other examples include a PWM ofthe voltage, current, and force. Other sensor(s) may be provided tomeasure physical parameters of the physical system in addition to theposition measured by the position sensor 472. In some aspects, the othersensor(s) can include sensor arrangements such as those described inU.S. Pat. No. 9,345,481, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSORSYSTEM, which issued on May 24, 2016, which is herein incorporated byreference in its entirety; U.S. Patent Application Publication No.2014/0263552, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM,which published on Sep. 18, 2014, which is herein incorporated byreference in its entirety; and U.S. patent application Ser. No.15/628,175, tided TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF ASURGICAL STAPLING AND CUTTING INSTRUMENT, filed Jun. 20, 2017, which isherein incorporated by reference in its entirety. In a digital signalprocessing system, an absolute positioning system is coupled to adigital data acquisition system where the output of the absolutepositioning system will have a finite resolution and sampling frequency.The absolute positioning system may comprise a compare-and-combinecircuit to combine a computed response with a measured response usingalgorithms, such as a weighted average and a theoretical control loop,that drive the computed response towards the measured response. Thecomputed response of the physical system may take into accountproperties like mass, inertial, viscous friction, inductance resistance,etc., to predict what the states and outputs of the physical system willbe by knowing the input.

The absolute positioning system may provide an absolute position of thedisplacement member upon power-up of the instrument, without retractingor advancing the displacement member to a reset (zero or home) positionas may be required with conventional rotary encoders that merely countthe number of steps forwards or backwards that the motor 482 has takento infer the position of a device actuator, drive bar, knife, or thelike.

A sensor 474, such as, for example, a strain gauge or a micro-straingauge, may be configured to measure one or more parameters of the endeffector, such as, for example, the amplitude of the strain exerted onthe anvil during a clamping operation, which can be indicative of theclosure forces applied to the anvil. The measured strain may beconverted to a digital signal and provided to the processor 462.Alternatively, or in addition to the sensor 474, a sensor 476, such as,for example, a load sensor, can measure the closure force applied by theclosure drive system to the anvil. The sensor 476, such as, for example,a load sensor, can measure the firing force applied to an I-beans in afiring stroke of the surgical instrument or tool. The I-beam isconfigured to engage a wedge sled, which is configured to upwardly camstaple drivers to force out staples into deforming contact with ananvil. The I-bran also may include a sharpened cutting edge that can beused to sever tissue as the I-beam is advanced distally by the firingbar. Alternatively, a current sensor 478 can be employed to measure thecurrent drawn by the motor 482. The force required to advance the firingmember can correspond to the current drawn by the motor 482, forexample. The measured force may be converted to a digital signal andprovided to the processor 462.

In one form, the strain gauge sensor 474 can be used to measure theforce applied to the tissue by the end effector. A strain gauge can becoupled to the end effector to measure the force on the tissue beingtreated by the end effector. A system for measuring forces applied tothe tissue grasped by the end effector may comprise a strain gaugesensor 474, such as, for example, a micro-strain gauge, that can beconfigured to measure one or more parameters of the end effector, forexample. In one aspect, the strain gauge sensor 474 can measure theamplitude or magnitude of the strain exerted on a jaw member of an endeffector during a clamping operation, which can be indicative of thetissue compression. The measured strain can be converted to a digitalsignal and provided to a processor 462 of the microcontroller 461. Aload sensor 476 can measure the force used to operate the knife element,for example, to cut the tissue captured between the anvil and the staplecartridge. A magnetic field sensor can be employed to measure thethickness of the captured tissue. The measurement of the magnetic fieldsensor also may be converted to a digital signal and provided to theprocessor 462.

The measurements of the tissue compression, the tissue thickness, and/orthe force required to close the end effector on the tissue, asrespectively measured by the sensors 474, 476, can be used by themicrocontroller 461 to characterize the selected position of the firingmember and/or the corresponding value of the speed of the firing member.In one instance, a memory 468 may store a technique, an equation, and/ora lookup table which can be employed by the microcontroller 461 in theassessment.

The control system 470 of the surgical instrument or tool also maycomprise wired or wireless communication circuits to communicate withthe modular communication hub 203 as shown in FIGS. 5 and 6.

FIG. 8 illustrates a surgical instrument or tool comprising a pluralityof motors which can be activated to perform various functions. Incertain instances, a first motor can be activated to perform a firstfunction, a second motor can be activated to perform a second function,a third motor can be activated to perform a third function, a fourthmotor can be activated to perform a fourth function, and so on. Incertain instances, the plurality of motors of robotic surgicalinstrument 600 can be individually activated to cause firing, closure,and/or articulation motions in the end effector. The firing closure,and/or articulation motions can be transmitted to the end effectorthrough a shaft assembly, for example.

In certain instances, the surgical instrument system or tool may includea fining motor 602. The firing motor 602 may be operably coupled to afiring motor drive assembly 604 which can be configured to transmitfiring motions, generated by the motor 602 to the end effector, inparticular to displace the I-beam element. In certain instances, thefiring motions generated by the motor 602 may cause the staples to bedeployed from the staple cartridge into tissue captured by the endeffector and/or the cutting edge of the I-bean element to be advanced tocut the captured tissue, for example. The I-beam element may beretracted by reversing the direction of the motor 602.

In certain instances, the surgical instrument or tool may include aclosure motor 603. The closure motor 603 may be operably coupled to aclosure motor drive assembly 605 which can be configured to transmitclosure motions, generated by the motor 603 to the end effector, inparticular to displace a closure tube to close the anvil and compresstissue between the anvil and the staple cartridge. The closure motionsmay cause the end effector to transition from an open configuration toan approximated configuration to capture tissue, for example. The endeffector may be transitioned to an open position by reversing thedirection of the motor 603.

In certain instances, the surgical instrument or tool may include one ormore articulation motors 606 a, 606 b, for example. The motors 606 a,606 b may be operably coupled to respective articulation motor driveassemblies 608 a, 608 b, which can be configured to transmitarticulation motions generated by the motors 606 a, 606 b to the endeffector. In certain instances, the articulation motions may cause theend effector to articulate relative to the shaft, for example.

As described herein, the surgical instrument or tool may include aplurality of motors which may be configured to perform variousindependent functions. In certain instances, the plurality of motors ofthe surgical instrument or tool can be individually or separatelyactivated to perform one or more functions while the other motors remaininactive. For example, the articulation motors 606 a, 606 b can beactivated to cause the end effector to be articulated while the firingmotor 602 remains inactive. Alternatively, the firing motor 602 can beactivated to fire the plurality of staples, and/or to advance thecutting edge, while the articulation motor 606 remains inactive.Furthermore, the closure motor 603 may be activated simultaneously withthe firing motor 602 to cause the closure tube and the I-beam element toadvance distally as described in more detail hereinbelow.

In certain instances, the surgical instrument or tool may include acommon control module 610 which can be employed with a plurality ofmotors of the surgical instrument or tool In certain instances, thecommon control module 610 may accommodate one of the plurality of motorsat a time. For example, the common control module 610 can be couplableto and separable from the plurality of motors of the robotic surgicalinstrument individually. In certain instances, a plurality of the motorsof the surgical instrument or tool may share one or more common controlmodules such as the common control module 610. In certain instances, aplurality of motors of the surgical instrument or tool can beindividually and selectively engaged with the common control module 610.In certain instances, the common control module 610 can be selectivelyswitched from interfacing with one of a plurality of motors of thesurgical instrument or tool to interfacing with another one of theplurality of motors of the surgical instrument or tool.

In at least one example, the common control module 610 can beselectively switched between operable engagement with the articulationmotors 606 a, 606 b and operable engagement with either the firing motor602 or the closure motor 603. In at least one example, as illustrated inFIG. 8, a switch 614 can be moved or transitioned between a plurality ofpositions and/or states. In a first position 616, the switch 614 mayelectrically couple the common control module 610 to the firing motor602; in a second position 617, the switch 614 may electrically couplethe common control module 610 to the closure motor 603; in a thirdposition 618 a, the switch 614 may electrically couple the commoncontrol module 610 to the first articulation motor 606 a; and in afourth position 618 b, the switch 614 may electrically couple the commoncontrol module 610 to the second articulation motor 606 b, for example.In certain instances, separate common control modules 610 can beelectrically coupled to the firing motor 602, the closure motor 603, andthe articulations motor 606 a, 606 b at the same time. In certaininstances, the switch 614 may be a mechanical switch, anelectromechanical switch, a solid-state switch, or any suitableswitching mechanism.

Each of the motors 602, 603, 606 a, 606 b may comprise a torque sensorto measure the output torque on the shaft of the motor. The force on anend effector may be sensed in any conventional manner, such as by forcesensors on the outer sides of the jaws or by a torque sensor for themotor actuating the jaws.

In various instances, as illustrated in FIG. 8, the common controlmodule 610 may comprise a motor driver 626 which may comprise one ormore H-Bridge FETs. The motor driver 626 may modulate the powertransmitted from a power source 628 to a motor coupled to the commoncontrol module 610 based on input from a microcontroller 620 (the“controller”), for example. In certain instances, the microcontroller620 can be employed to determine the current drawn by the motor, forexample, while the motor is coupled to the common control module 610, asdescribed herein.

In certain instances, the microcontroller 620 may include amicroprocessor 622 (the “processor”) and one or more non-transitorycomputer-readable mediums or memory units 624 (the “memory”). In certaininstances, the memory 624 may store various program instructions, whichwhen executed may cause the processor 622 to perform a plurality offunctions and/or calculations described herein. In certain instances,one or more of the memory units 624 may be coupled to the processor 622,for example.

In certain instances, the power source 628 can be employed to supplypower to the microcontroller 620, for example. In certain instances, thepower source 628 may comprise a battery (or “battery pack” or “powerpack”), such as a lithium-ion battery, for example.

In certain instances, the battery pack may be configured to bereleasably mounted to a handle for supplying power to the surgicalinstrument 600. A number of battery cells connected in series may beused as the power source 628. In certain instances, the power source 628may be replaceable and/or rechargeable, for example.

In various instances, the processor 622 may control the motor driver 626to control the position, direction of rotation, and/or velocity of amotor that is coupled to the common control module 610. In certaininstances, the processor 622 can signal the motor driver 626 to stopand/or disable a motor that is coupled to the common control module 610.It should be understood that the term “processor” as used hereinincludes any suitable microprocessor, microcontroller, or other basiccomputing device that incorporates the functions of a computer's centralprocessing unit (CPU) on an integrated circuit or, at most, a fewintegrated circuits. The processor can be a multipurpose, programmabledevice that accepts digital data as input, processes it according toinstructions stored in its memory, and provides results as output. Itcan be an example of sequential digital logic, as it may have internalmemory. Processors may operate on numbers and symbols represented in thebinary numeral system.

The processor 622 may be any single-core or multicore processor such asthose known under the trade name ARM Cortex by Texas Instruments. Incertain instances, the microcontroller 620 may be an LM 4F230H5QR,available from Texas Instruments, for example. In at least one example,the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F Processor Corecomprising an on-chip memory of 256 KB single-cycle flash memory, orother non-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle SRAM, an internal ROMloaded with StellarisWare® software, a 2 KB EEPROM, one or more PWMmodules, one or more QEI analogs, one or more 12-bit ADCs with 12 analoginput channels, among other features that are readily available for theproduct datasheet. Other microcontrollers may be readily substituted foruse with the module 4410. Accordingly, the present disclosure should notbe limited in this context.

The memory 624 may include program instructions for controlling each ofthe motors of the surgical instrument 600 that are couplable to thecommon control module 610. For example, the memory 624 may includeprogram instructions for controlling the firing motor 602, the closuremotor 603, and the articulation motors 606 a, 6066. Such programinstructions may cause the processor 622 to control the firing, closure,and articulation functions in accordance with inputs from algorithms orcontrol programs of the surgical instrument or tool.

One or more mechanisms and/or sensors such as, for example, sensors 630can be employed to alert the processor 622 to the program instructionsthat should be used in a particular setting. For example, the sensors630 may alert the processor 622 to use the program instructionsassociated with firing, closing, and articulating the end effector. Incertain instances, the sensors 630 may comprise position sensors whichcan be employed to sense the position of the switch 614, for example.Accordingly, the processor 622 may use the program instructionsassociated with firing the I-beam of the end effector upon detecting,through the sensors 630 for example, that the switch 614 is in the firstposition 616; the processor 622 may use the program instructionsassociated with closing the anvil upon detecting, through the sensors630 for example, that the switch 614 is in the second position 617; andthe processor 622 may use the program instructions associated witharticulating the end effector upon detecting, through the sensors 630for example, that the switch 614 is in the third or fourth position 618a, 618 b.

FIG. 9 illustrates a diagram of a situationally awry surgical system5100, in accordance with at least one aspect of the present disclosure.In some exemplifications, the data sources 5126 may include, forexample, the modular devices 5102 (which can include sensors configuredto detect parameters associated with the patient and/or the modulardevice itself), databases 5122 (e.g., an EMR database containing patientrecords), and patient monitoring devices 5124 (e.g., a blood pressure(BP) monitor and an electrocardiography (EKG) monitor). The surgical hub5104 can be configured to derive the contextual information pertainingto the surgical procedure from the data based upon, for example, theparticular combination(s) of received data or the particular order inwhich the data is received from the data sources 5126. The contextualinformation inferred from the received data can include, for example,the type of surgical procedure being performed, the particular step ofthe surgical procedure that the surgeon is performing, the type oftissue being operated on, or the body cavity that is the subject of theprocedure. This ability by some aspects of the surgical hub 5104 toderive or infer information related to the surgical procedure fromreceived data can be referred to as “situational awareness.” In anexemplification, the surgical hub 5104 can incorporate a situationalawareness system, which is the hardware and/or programming associatedwith the surgical hub 5104 that derives contextual informationpertaining to the surgical procedure from the received data.

The situational awareness system of the surgical hub 5104 can beconfigured to derive the contextual information from the data receivedfrom the data sources 5126 in a variety of different ways. In anexemplification, the situational awareness system can include a patternrecognition system, or machine learning system (e.g., an artificialneural network), that has been trained on training data to correlatevarious inputs (e.g., data from databases 5122, patient monitoringdevices 5124, and/or modular devices 5102) to corresponding contextualinformation regarding a surgical procedure. In other words, a machinelearning system can be trained to accurately derive contextualinformation regarding a surgical procedure from the provided inputs. Inexamples, the situational awareness system can include a lookup tablestoring pre-characterized contextual information regarding a surgicalprocedure in association with one or more inputs (or ranges of inputs)corresponding to the contextual information. In response to a query withone or more inputs, the lookup table can return the correspondingcontextual information for the situational awareness system forcontrolling the modular devices 5102. In examples, the contextualinformation received by the situational awareness system of the surgicalhub 5104 can be associated with a particular control adjustment or setof control adjustments for one or more modular devices 5102. Inexamples, the situational awareness system can include a further machinelearning system, lookup table, or other such system, which generates orretrieves one or more control adjustments for one or more modulardevices 5102 when provided the contextual information as input.

A surgical hub 5104 incorporating a situational awareness system canprovide a number of benefits for the surgical system 5100. One benefitmay include improving the interpretation of sensed and collected data,which would in turn improve the processing accuracy and/or the usage ofthe data during the course of a surgical procedure. To return to aprevious example, a situationally aware surgical hub 5104 coulddetermine what type of tissue was being operated on; therefore, when anunexpectedly high force to close the surgical instrument's end effectoris detected, the situationally aware surgical hub 5104 could correctlyramp up or ramp down the motor of the surgical instrument for the typeof tissue.

The type of tissue being operated can affect the adjustments that aremade to the compression rate and load thresholds of a surgical staplingand cutting instrument for a particular tissue gap measurement. Asituationally aware surgical hub 5104 could infer whether a surgicalprocedure being performed is a thoracic or an abdominal procedure,allowing the surgical hub 5104 to determine whether the tissue clampedby an end effector of the surgical stapling and cutting instrument islung (for a thoracic procedure) or stomach (for an abdominal procedure)tissue. The surgical hub 5104 could then adjust the compression rate andload thresholds of the surgical stapling and cutting instrumentappropriately for the type of tissue.

The type of body cavity being operated in during an insufflationprocedure can affect the function of a smoke evacuator. A situationallyaware surgical hub 5104 could determine whether the surgical site isunder pressure (by determining that the surgical procedure is utilizinginsufflation) and determine the procedure type. As a procedure type canbe generally performed in a specific body cavity, the surgical hub 5104could then control the motor rate of the smoke evacuator appropriatelyfor the body cavity being operated in. Thus, a situationally awaresurgical hub 5104 could provide a consistent amount of smoke evacuationfor both thoracic and abdominal procedures.

The type of procedure being performed can affect the optimal energylevel for an ultrasonic surgical instrument or radio frequency (RE)electrosurgical instrument to operate at. Arthroscopic procedures, forexample, may require higher energy levels because the end effector ofthe ultrasonic surgical instrument or RF electrosurgical instrument isimmersed in fluid. A situationally aware surgical hub 5104 coulddetermine whether the surgical procedure is an arthroscopic procedure.The surgical hub 5104 could then adjust the RF power level or theultrasonic amplitude of the generator (i.e., “energy level”) tocompensate for the fluid filled environment. Relatedly, the type oftissue being operated on can affect the optimal energy level for anultrasonic surgical instrument or RF electrosurgical instrument tooperate at. A situational v aware surgical hub 5104 could determine whattype of surgical procedure is being performed and then customize theenergy level for the ultrasonic surgical instrument or RFelectrosurgical instrument, respectively, according to the expectedtissue profile for the surgical procedure. Furthermore, a situationallyaware surgical hub 5104 can be configured to adjust the energy level forthe ultrasonic surgical instrument or RF electrosurgical instrumentthroughout the course of a surgical procedure, rather than just on aprocedure-by-procedure basis. A situationally aware surgical hub 5104could determine what step of the surgical procedure is being performedor will subsequently be performed and then update the control algorithmsfor the generator and/or ultrasonic surgical instrument or RFelectrosurgical instrument to set the energy level at a valueappropriate for the expected tissue type according to the surgicalprocedure step.

In examples, data can be drawn from additional data sources 5126 toimprove the conclusions that the surgical hub 5104 draws from one datasource 5126. A situationally aware surgical hub 5104 could augment datathat it receives from the modular devices 5102 with contextualinformation that it has built up regarding the surgical procedure fromother data sources 5126. For example, a situationally aware surgical hub5104 can be configured to determine whether hemostasis has occurred(i.e., whether bleeding at a surgical site has stopped) according tovideo or image data received from a medical imaging device. However, insome cases the video or image data can be inconclusive. Therefore, in anexemplification, the surgical hub 5104 can be further configured tocompare a physiologic measurement (e.g., blood pressure sensed by a BPmonitor communicably connected to the surgical hub 5104) with the visualor image data of hemostasis (e.g., from a medical imaging device 124(FIG. 2) communicably coupled to the surgical hub 5104) to make adetermination on the integrity of the staple line or tissue weld. Inother words, the situational awareness system of the surgical hub 5104can consider the physiological measurement data to provide additionalcontext in analyzing the visualization data. The additional context canbe useful when the visualization data may be inconclusive or incompleteon its own.

For example, a situationally aware surgical hub 5104 could proactivelyactivate the generator to which an RF electrosurgical instrument isconnected if it determines that a subsequent step of the procedurerequires the use of the instrument Proactively activating the energysource can allow the instrument to be ready for use a soon as thepreceding step of the procedure is completed.

The situationally aware surgical hub 5104 could determine whether thecurrent or subsequent step of the surgical procedure requires adifferent view or degree of magnification on the display according tothe feature(s) at the surgical site that the surgeon is expected to needto view. The surgical hub 5104 could then proactively change thedisplayed view (supplied by, e.g., a medical imaging device for thevisualization system 108) accordingly so that the display automaticallyadjusts throughout the surgical procedure.

The situationally aware surgical hub 5104 could determine which step ofthe surgical procedure is being performed or will subsequently beperformed and whether particular data or comparisons between data willbe required for that step of the surgical procedure. The surgical hub5104 can be configured to automatically call up data screens based uponthe step of the surgical procedure being performed, without waiting forthe surgeon to ask for the particular information.

Errors may be checked during the setup of the surgical procedure orduring the course of the surgical procedure. For example, thesituationally aware surgical hub 5104 could determine whether theoperating theater is setup properly or optimally for the surgicalprocedure to be performed. The surgical hub 5104 can be configured todetermine the type of surgical procedure being performed, retrieve thecorresponding checklists, product location, or setup needs (e.g., from amemory), and then compare the current operating theater layout to thestandard layout for the type of surgical procedure that the surgical hub5104 determines is being performed. In some exemplifications, thesurgical hub 5104 can be configured to compare the list of items for theprocedure and/or a list of devices paired with the surgical hub 5104 toa recommended or anticipated manifest of items and/or devices for thegiven surgical procedure. If there are any discontinuities between thelists, the surgical hub 5104 can be configured to provide an alertindicating that a particular modular device 5102, patient monitoringdevice 5124, and/or other surgical item is missing. In someexemplifications, the surgical hub 5104 can be configured to determinethe relative distance or position of the modular devices 5102 andpatient monitoring devices 5124 via proximity sensors, for example. Thesurgical hub 5104 can compare the relative positions of the devices to arecommended or anticipated Layout for the particular surgical procedure.If there are any discontinuities between the layouts, the surgical hub5104 can be configured to provide an alert indicating that the currentlayout for the surgical procedure deviates from the recommended layout.

The situationally aware surgical hub 5104 could determine whether thesurgeon (or other medical personnel) was making an error or otherwisedeviating from the expected course of action during the course of asurgical procedure. For example, the surgical hub 5104 can be configuredto determine the type of surgical procedure being performed, retrievethe corresponding list of steps or order of equipment usage (e.g., froma memory), and then compare the steps being performed or the equipmentbeing used during the course of the surgical procedure to the expectedsteps or equipment for the type of surgical procedure that the surgicalhub 5104 determined is being performed. In some exemplifications, thesurgical hub 5104 can be configured to provide an alert indicating thatan unexpected action is being performed or an unexpected device is beingutilized at the particular step in the surgical procedure.

The surgical instruments (and other modular devices 5102) may beadjusted for the particular context of each surgical procedure (such asadjusting to different tissue types) and validating actions during asurgical procedure. Next steps, data, and display adjustments may beprovided to surgical instruments (and other modular devices 5102) in thesurgical theater according to the specific context of the procedure.

FIG. 10 illustrates a timeline 5200 of an illustrative surgicalprocedure and the contextual information that a surgical hub 5104 canderive from the data received from the data sources 5126 at each step inthe surgical procedure. In the following description of the timeline5200 illustrated in FIG. 9, reference should also be made to FIG. 9. Thetimeline 5200 may depict the typical steps that would be taken by thenurses, surgeons, and other medical personnel during the course of alung segmentectomy procedure, beginning with setting up the operatingtheater and ending with transferring the patient to a post-operativerecovery room. The situationally aware surgical hub 5104 may receivedata from the data sources 5126 throughout the course of the surgicalprocedure, including data generated each time medical personnel utilizea modular device 5102 that is paired with the surgical hub 5104. Thesurgical hub 5104 can receive this data from the paired modular devices5102 and other data sources 5126 and continually derive inferences i.e.,contextual information) about the ongoing procedure as new data isreceived, such as which step of the procedure is being performed at anygiven time. The situational awareness system of the surgical hub 5104can be able to, for example, record data pertaining to the procedure forgenerating reports, verify the steps being taken by the medicalpersonnel, provide data or prompts (e.g., via a display screen) that maybe pertinent for the particular procedural step, adjust modular devices5102 based on the context (e.g., activate monitors, adjust the FOV ofthe medical imaging device, or change the energy level of an ultrasonicsurgical instrument or RF electrosurgical instrument), and take anyother such action described herein.

As the first step 5202 in this illustrative procedure, the hospitalstaff members may retrieve the patient's EMR from the hospital's EMRdatabase. Based on select patient data in the EMR, the surgical hub 5104determines that the procedure to be performed is a thoracic procedure.Second 5204, the staff members may scan the incoming medical suppliesfor the procedure. The surgical hub 5104 cross-references the scannedsupplies with a list of supplies that can be utilized in various typesof procedures and confirms that the mix of supplies corresponds to athoracic procedure. Further, the surgical hub 5104 may also be able todetermine that the procedure is not a wedge procedure (because theincoming supplies either lack certain supplies that are necessary for athoracic wedge procedure or do not otherwise correspond to a thoracicwedge procedure). Third 5206, the medical personnel may scan the patientband via a scanner 5128 that is communicably connected to the surgicalhub 5104. The surgical hub 5104 can then confirm the patients identitybased on the scanned data. Fourth 5208, the medical staff turns on theauxiliary equipment. The auxiliary equipment being utilized can varyaccording to the type of surgical procedure and the techniques to beused by the surgeon, but in this illustrative case they include a smokeevacuator, insuffaltor, and medical imaging device. When activated, theauxiliary equipment that are modular devices 5102 can automatically pairwith the surgical hub 5104 that may be located within a particularvicinity of the modular devices 5102 as part of their initializationprocess. The surgical hub 5104 can then derive contextual informationabout the surgical procedure by detecting the types of modular devices5102 that pair with it during this pre-operative or initializationphase. In this particular example, the surgical hub 5104 may determinethat the surgical procedure is a VATS procedure based on this particularcombination of paired modular devices 5102. Based on the combination ofthe data from the patient's EMR, the list of medical supplies to be usedin the procedure, and the type of modular devices 5102 that connect tothe hub, the surgical hub 5104 can generally infer the specificprocedure that the surgical team will be performing. Once the surgicalhub 5104 knows what specific procedure is being performed, the surgicalhub 5104 can then retrieve the steps of that procedure from a memory orfrom the cloud and then cross-reference the data it subsequentlyreceives from the connected data sources 5126 (e.g., modular devices5102 and patient monitoring devices 5124) to infer what step of thesurgical procedure the surgical team is performing. Fifth 5210, thestaff members attach the EKG electrodes and other patient monitoringdevices 5124 to the patient. The EKG electrodes and other patientmonitoring devices 5124 may pair with the surgical hub 5104. As thesurgical hub 5104 begins receiving data from the patient monitoringdevices 5124, the surgical hub 5104 may confirm that the patient is inthe operating theater, as described in the process 5207, for example.Sixth 5212, the medical personnel may induce anesthesia in the patient.The surgical hub 5104 can infer that the patient is under anesthesiabased on data from the modular devices 5102 and/or patient monitoringdevices 5124, including EKG data, blood pressure data, ventilator data,or combinations thereof, for example. Upon completion of the sixth step5212, the pre-operative portion of the lung segmentectomy procedure iscompleted and the operative portion begins.

Seventh 5214, the patient's lung that is being operated on may becollapsed (while ventilation is switched to the contralateral lung). Thesurgical hub 5104 can infer from the ventilator data that the patientslung has been collapsed, for example. The surgical hub 5104 can inferthat the operative portion of the procedure has commenced as it cancompare the detection of the patient's lung collapsing to the expectedsteps of the procedure (which can be accessed or retrieved previously)and thereby determine that collapsing the lung can be the firstoperative step in this particular procedure. Eighth 5216, the medicalimaging device 5108 (e.g., a scope) may be inserted and video from themedical imaging device may be initiated. The surgical hub 5104 mayreceive the medical imaging device data (i.e., video or image data)through its connection to the medical imaging device. Upon receipt ofthe medical imaging device data, the surgical hub 5104 can determinethat the laparoscopic portion of the surgical procedure has commenced.Further, the surgical hub 5104 can determine that the particularprocedure being performed is a segmentectomy, as opposed to a lobectomy(note that a wedge procedure has already been discounted by the surgicalhub 5104 based on data received at the second step 5204 of theprocedure). The data from the medical imaging device 124 (FIG. 2) can beutilized to determine contextual information regarding the type ofprocedure being performed in a number of different ways, including bydetermining the angle at which the medical imaging device is orientedwith respect to the visualization of the patient's anatomy, monitoringthe number or medical imaging devices being utilized (i.e., that areactivated and paired with the surgical hub 5104), and monitoring thetypes of visualization devices utilized. For example, one technique forperforming a VATS lobectomy may place the camera in the lower anteriorcorner of the patient's chest cavity above the diaphragm, whereas onetechnique for performing a VATS segmentectomy places the camera in ananterior intercostal position relative to the segmental fissure. Usingpattern recognition or machine learning techniques, for example, thesituational awareness system can be trained to recognize the positioningof the medical imaging device according to the visualization of thepatient's anatomy. An example technique for performing a VATS lobectomymay utilize a single medical imaging device. An example technique forperforming a VATS segmentectomy utilizes multiple cameras. An exampletechnique for performing a VATS segmentectomy utilizes an infrared lightsource (which can be communicably coupled to the surgical hub as part ofthe visualization system) to visualize the segmental fissure, which isnot utilized in a VATS lobectomy. By tracking any or all of this datafrom the medical imaging device 5108, the surgical hub 5104 can therebydetermine the specific type of surgical procedure being performed and/orthe technique being used for a particular type of surgical procedure.

Ninth 5218, the surgical team may begin the dissection step of theprocedure. The surgical hub 5104 can infer that the surgeon is in theprocess of dissecting to mobilize the patient's lung because it receivesdata from the RF or ultrasonic generator indicating that an energyinstrument is being fired. The surgical hub 5104 can cross-reference thereceived data with the retrieved steps of the surgical procedure todetermine that an energy instrument being fired at this point in theprocess (i.e., after the completion of the previously discussed steps ofthe procedure) corresponds to the dissection step. Tenth 5220, thesurgical team may proceed to the ligation step of the procedure. Thesurgical hub 5104 can infer that the surgeon is ligating arteries andveins because it may receive data from the surgical stapling and cuttinginstrument indicating that the instrument is being fired. Similar to theprior step, the surgical hub 5104 can derive this inference bycross-referencing the receipt of data from the surgical stapling andcutting instrument with the retrieved steps in the process. Eleventh5222, the segmentectomy portion of the procedure can be performed. Thesurgical hub 5104 can infer that the surgeon is transecting theparenchyma based on data from the surgical stapling and cuttinginstrument, including data from its cartridge. The cartridge data cancorrespond to the size or type of staple being feed by the instrument,for example. As different types of staples are utilized for differenttypes of tissues, the cartridge data can thus indicate the type oftissue being stapled and/or transected. In this case, the type of staplebeing fired is utilized for parenchyma (or other similar tissue types),which allows the surgical hub 5104 to infer that the segmentectomyportion of the procedure is being performed. Twelfth 5224, the nodedissection step is then performed. The surgical hub 5104 can infer thatthe surgical team is dissecting the node and performing a leak testbased on data received from the generator indicating that an RF orultrasonic instrument is being fired. For this particular procedure, anRF or ultrasonic instrument being utilized after parenchyma wastransected corresponds to the node dissection step, which allows thesurgical hub 5104 to make this inference. It should be noted thatsurgeons regularly switch back and forth between surgicalstapling/cutting instruments and surgical energy (e.g., RF orultrasonic) instruments depending upon the particular step in theprocedure because different instruments are better adapted forparticular tasks. Therefore, the particular sequence in which thestapling/nutting instruments and surgical energy instruments are usedcan indicate what step of the procedure the surgeon is performing. Uponcompletion of the twelfth step 5224, the incisions and closed up and thepost-operative portion of the procedure may begin.

Thirteenth 5226, the patient's anesthesia can be reversed. The surgicalhub 5104 can infer that the patient is emerging from the anesthesiabased on the ventilator data (i.e., the patient's breathing rate beginsincreasing), for example. Lastly, the fourteenth step 5228 may be thatthe medical personnel remove the various patient monitoring devices 5124from the patient. The surgical hub 5104 can thus infer that the patientis being transferred to a recovery room when the hub loses EKG, BP, andother data from the patient monitoring devices 5124. As can be seen fromthe description of this illustrative procedure, the surgical hub 5104can determine or infer when each step of a given surgical procedure istaking place according to data received from the various data sources5126 that are communicably coupled to the surgical hub 5104.

In addition to utilizing the patient data from EAR database(s) to inferthe type of surgical procedure that is to be performed, as illustratedin the first step 5202 of the timeline 5200 depicted in FIG. 10, thepatient data can also be utilized by a situationally aware surgical hub5104 to generate control adjustments for the paired modular devices5102.

FIG. 11 is a block diagram of the computer implemented interactivesurgical system, in accordance with at least one aspect of the presentdisclosure. In one aspect, the computer-implemented interactive surgicalsystem may be configured to monitor and analyze data related to theoperation of various surgical systems that include surgical hubs,surgical instruments, robotic devices and operating theaters orhealthcare facilities. The computer-implemented interactive surgicalsystem may comprise a cloud-based analytics system. Although thecloud-based analytics system may be described as a surgical system, itmay not be necessarily limited as such and could be a cloud-basedmedical system generally. As illustrated in FIG. 11, the cloud-basedanalytics system may comprise a plurality of surgical instruments 7012(may be the same or similar to instruments 112), a plurality of surgicalhubs 7006 (may be the same or similar to hubs 106), and a surgical datanetwork 7001 (may be the same or similar to network 201) to couple thesurgical hubs 7006 to the cloud 7004 (may be the same or similar tocloud 204). Each of the plurality of surgical hubs 7006 may becommunicatively coupled to one or more surgical instruments 7012. Thehubs 7006 may also be communicatively coupled to the cloud 7004 of thecomputer-implemented interactive surgical system via the network 7001.The cloud 7004 may be a remote centralized source of hardware andsoftware for storing, manipulating, and communicating data generatedbased on the operation of various surgical systems. As shown in FIG. 11,access to the cloud 7004 may be achieved via the network 7001, which maybe the Internet or some other suitable computer network. Surgical hubs7006 that may be coupled to the cloud 7004 can be considered the clientside of the cloud computing system (i.e., cloud-based analytics system).Surgical instruments 7012 may be paired with the surgical hubs 7006 forcontrol and implementation of various surgical procedures or operationsas described herein.

In addition, surgical instruments 7012 may comprise transceivers fordata transmission to and from their corresponding surgical hubs 7006(which may also comprise transceivers). Combinations of surgicalinstruments 7012 and corresponding hubs 7006 may indicate particularlocations, such as operating theaters in healthcare facilities (e.g.,hospitals), for providing medical operations. For example, the memory ofa surgical hub 7006 may store location data. As shown in FIG. 11, thecloud 7004 comprises central servers 7013 (may be same or similar toremote server 7013), hub application servers 7002, data analyticsmodules 7034, and an input/output (“I/O”) interface 7006. The centralservers 7013 of the cloud 7004 collectively administer the cloudcomputing system, which includes monitoring requests by client surgicalhubs 7006 and managing the processing capacity of the cloud 7004 forexecuting the requests. Each of the central servers 7013 may compriseone or more processors 7008 coupled to suitable memory devices 7010which can include volatile memory such as random-access memory (RAM) andnon-volatile memory such as magnetic storage devices. The memory devices7010 may comprise machine executable instructions that when executedcause the processors 7008 to execute the data analytics modules 7034 forthe cloud-based data analysis, operations, recommendations and otheroperations described below. Moreover, the processors 7008 can executethe data analytics modules 7034 independently or in conjunction with hubapplications independently executed by the hubs 7006. The centralservers 7013 also may comprise aggregated medical data databases 2212,which can reside in the memory 2210.

Based on connections to various surgical hubs 7006 via the network 7001,the cloud 7004 can aggregate data from specific data generated byvarious surgical instruments 7012 and their corresponding hubs 7006.Such aggregated data may be stored within the aggregated medicaldatabases 7012 of the cloud 7004. In particular, the cloud 7004 mayadvantageously perform data analysis and operations on the aggregateddata to yield insights and/or perform functions that individual hubs7006 could not achieve on their own. To this end, as shown in FIG. 11,the cloud 7004 and the surgical hubs 7006 are communicatively coupled totransmit and receive information. The I/O interface 7006 is connected tothe plurality of surgical hubs 7006 via the network 7001. In this way,the I/O interface 7006 can be configured to transfer information betweenthe surgical hubs 7006 and the aggregated medical data databases 7011.Accordingly, the I/O interface 7006 may facilitate read/write operationsof the cloud-based analytics system. Such read; write operations may beexecuted in response to requests from hubs 7006. These requests could betransmitted to the hubs 7006 through the hub applications. The I/Ointerface 7006 may include one or more high speed data ports, which mayinclude universal serial bus (USB) ports, IEEE 1394 ports, as well asWi-Fi and Bluetooth I/O interfaces for connecting the cloud 7004 to hubs7006. The hub application servers 7002 of the cloud 7004 may beconfigured to host and supply shared capabilities to softwareapplications (e.g., hub applications) executed by surgical hubs 7006.For example, the hub application servers 7002 may manage requests madeby the hub applications through the hubs 7006, control access to theaggregated medical data databases 7011, and perform load balancing. Thedata analytic modules 7034 are described in further detail withreference to FIG. 12.

The particular cloud computing system configuration described in thepresent disclosure may be specifically designed to address variousissues arising in the context of medical operations and proceduresperformed using medical devices, such as the surgical instruments 7012,112. In particular, the surgical instruments 7012 may be digitalsurgical devices configured to interact with the cloud 7004 forimplementing techniques to improve the performance of surgicaloperations. Various surgical instruments 7012 and/or surgical hubs 7006may comprise touch-controlled user interfaces such that clinicians maycontrol aspects of interaction between the surgical instruments 7012 andthe cloud 7004. Other suitable user interfaces for control such asauditory controlled user interfaces can also be used.

FIG. 12 is a block diagram which illustrates the functional architectureof the computer-implemented interactive surgical system, in accordancewith at least one aspect of the present disclosure. The cloud-basedanalytics system may include a plurality of data analytics modules 7034that may be executed by the processors 7008 of the cloud 7004 forproviding data analytic solutions to problems specifically arising inthe medical field. As shown in FIG. 12, the functions of the cloud-baseddata analytics modules 7034 may be assisted via hub applications 7014hosted by the hub application servers 7002 that may be accessed onsurgical hubs 7006. The cloud processors 7008 and hub applications 7014may operate in conjunction to execute the data analytic modules 7034.Application program interfaces (APIs) 7016 may define the set ofprotocols and routines corresponding to the hub applications 7014.Additionally, the APIs 7016 may manage the storing and retrieval of datainto and from the aggregated medical databases 7012 for the operationsof the applications 7014. The caches 7018 may also store data (e.g.,temporarily) and may be coupled to the APIs 7016 for more efficientretrieval of data used by the applications 7014. The data analyticsmodules 7034 in FIG. 12 may include modules for resource optimization7020, data collection and aggregation 7022, authorization and security7024, control program updating 7026, patient outcome analysis 7028,recommendations 7030, and data sorting and prioritization 7032. Othersuitable data analytics modules could also be implemented by the cloud7004, according to some aspects. In one aspect, the data analyticsmodules may be used for specific recommendations based on analyzingtrends, outcomes, and other data.

For example, the data collection and aggregation module 7022 could beused to generate self-describing data (e.g., metadata) includingidentification of notable features or configuration (e.g., trends),management of redundant data sets, and storage of the data in paireddata sets which can be grouped by surgery but not necessarily keyed toactual surgical dates and surgeons. In particular, pair data setsgenerated from operations of surgical instruments 7012 can compriseapplying a binary classification, e.g., a bleeding or a non-bleedingevent. More generally, the binary classification may be characterized aseither a desirable event (e.g., a successful surgical procedure) or anundesirable event e.g., a misfired or misused surgical instrument 7012).The aggregated self-describing data may correspond to individual datareceived from various groups or subgroups of surgical hubs 7006.Accordingly, the data collection and aggregation module 7022 cangenerate aggregated metadata or other organized data based on raw datareceived from the surgical hubs 7006. To this end, the processors 7008can be operationally coupled to the hub applications 7014 and aggregatedmedical data databases 7011 for executing the data analytics modules7034. The data collection and aggregation module 7022 may store theaggregated organized data into the aggregated medical data databases2212.

The resource optimization module 7020 can be configured to analyze thisaggregated data to determine an optimal usage of resources for aparticular or group of healthcare facilities. For example, the resourceoptimization module 7020 may determine an optimal order point ofsurgical stapling instruments 7012 for a group of healthcare facilitiesbased on corresponding predicted demand of such instruments 7012. Theresource optimization module 7020 might also assess the resource usageor other operational configurations of various healthcare facilities todetermine whether resource usage could be improved. Similarly, therecommendations module 7030 can be configured to analyze aggregatedorganized data from the data collection and aggregation module 7022 toprovide recommendations. For example, the recommendations module 7030could recommend to healthcare facilities (e.g., medical serviceproviders such as hospitals) that a particular surgical instrument 7012should be upgraded to an improved version based on a higher thanexpected error rate, for example. Additionally, the recommendationsmodule 7030 and/or resource optimization module 7020 could recommendbetter supply chain parameters such as product reorder points andprovide suggestions of different surgical instrument 7012, uses thereof,or procedure steps to improve surgical outcomes. The healthcarefacilities can receive such recommendations via corresponding surgicalhubs 7006. More specific recommendations regarding parameters orconfigurations of various surgical instruments 7012 can also beprovided. Hubs 7006 and/or surgical instruments 7012 each could alsohave display screens that display data or recommendations provided bythe cloud 7004.

The patient outcome analysis module 7028 can analyze surgical outcomesassociated with currently used operational parameters of surgicalinstruments 7012. The patient outcome analysis module 7028 may alsoanalyze and assess other potential operational parameters. In thisconnection, the recommendations module 7030 could recommend using theseother potential operational parameters based on yielding better surgicaloutcomes, such as better sealing or less bleeding. For example, therecommendations module 7030 could transmit recommendations to a surgical7006 regarding when to use a particular cartridge for a correspondingstapling surgical instrument 7012. Thus, the cloud-based analyticssystem, while controlling for common variables, may be configured toanalyze the large collection of raw data and to provide centralizedrecommendations over multiple healthcare facilities (advantageouslydetermined based on aggregated data). For example, the cloud-basedanalytics system could analyze, evaluate, and/or aggregate data based ontype of medical practice, type of patient, number of patients,geographic similarity between medical providers, which medicalproviders/facilities use similar types of instruments, etc., in a waythat no single healthcare facility alone would be able to analyzeindependently. The control program updating module 7026 could beconfigured to implement various surgical instrument 7012 recommendationswhen corresponding control programs are updated. For example, thepatient outcome analysis module 7028 could identify correlations linkingspecific control parameters with successful (or unsuccessful) results.Such correlations may be addressed when updated control programs aretransmitted to surgical instruments 7012 via the control programupdating module 7026. Updates to instruments 7012 that may betransmitted via a corresponding hub 7006 may incorporate aggregatedperformance data that was gathered and analyzed by the data collectionand aggregation module 7022 of the cloud 7004. Additionally, the patientoutcome analysis module 7028 and recommendations module 7030 couldidentify improved methods of using instruments 7012 based on aggregatedperformance data.

The cloud-based analytics system may include security featuresimplemented by the cloud 7004. These security features may be managed bythe authorization and security module 7024. Each surgical hub 7006 canhave associated unique credentials such as username, password, and othersuitable security credentials. These credentials could be stored in thememory 7010 and be associated with a permitted cloud access level. Forexample, based on providing accurate credentials, a surgical hub 7006may be granted access to communicate with the cloud to a predeterminedextent (e.g., may only engage in transmitting or receiving certaindefined types of information). To this end, the aggregated medical datadatabases 7011 of the cloud 7004 may comprise a database of authorizedcredentials for verifying the accuracy of provided credentials.Different credentials may be associated with varying levels ofpermission for interaction with the cloud 7004, such as a predeterminedaccess level for receiving the data analytics generated by the cloud7004. Furthermore, for security purposes, the cloud could maintain adatabase of hubs 7006, instruments 7012, and other devices that maycomprise a “black list” of prohibited devices. In particular, a surgicalhubs 7006 listed on the black list may not be permitted to interact withthe cloud, while surgical instruments 7012 listed on the black list maynot have functional access to a corresponding hub 7006 and/or may beprevented from fully functioning when paired to its corresponding hub7006. Additionally, or alternatively, the cloud 7004 may flaginstruments 7012 based on incompatibility or other specified criteria.In this manner, counterfeit medical devices and improper reuse of suchdevices throughout the cloud-based analytics system can be identifiedand addressed.

The surgical instruments 7012 may use wireless transceivers to transmitwireless signals that may represent, for example, authorizationcredentials for access to corresponding hubs 7006 and the loud 7004.Wired transceivers may also be used to transmit signals. Suchauthorization credentials can be stored in the respective memory devicesof the surgical instruments 7012. The authorization and security module7024 can determine whether the authorization credentials are accurate orcounterfeit. The authorization and security module 7024 may alsodynamically generate authorization credentials for enhanced security.The credentials could also be encrypted, such as by using hash-basedencryption. Upon transmitting proper authorization, the surgicalinstruments 7012 may transmit a signal to the corresponding hubs 7006and ultimately the cloud 7004 to indicate that the instruments 7012 areready to obtain and transmit medical data. In response, the cloud 7004may transition into a state enabled for receiving medical data forstorage into the aggregated medical data databases 7011. This datatransmission readiness could be indicated by a light indicator on theinstruments 7012, for example. The cloud 7004 can also transmit signalsto surgical instruments 7012 for updating their associated controlprograms. The cloud 7004 can transmit signals that are directed to aparticular class of surgical instruments 7012 (e.g., electrosurgicalinstruments) so that software updates to control programs axe onlytransmitted to the appropriate surgical instruments 7012. Moreover, thecloud 7004 could be used to implement system wide solutions to addresslocal or global problems based on selective data transmission andauthorization credentials. For example, if a group of surgicalinstruments 7012 are identified as having a common manufacturing defect,the cloud 7004 may change the authorization credentials corresponding tothis group to implement an operational lockout of the group.

The cloud-based analytics system may allow for monitoring multiplehealthcare facilities (e.g., medical facilities like hospitals) todetermine improved practices and recommend changes (via therecommendations module 2030, for example) accordingly. Thus, theprocessors 7008 of the cloud 7004 can analyze data associated with anindividual healthcare facility to identify the facility and aggregatethe data with other data associated with other healthcare facilities ina group. Groups could be defined based on similar operating practices orgeographical location, for example. In this way, the cloud 7004 mayprovide healthcare facility group wide analysis and recommendations. Thecloud-based analytics system could also be used for enhanced situationalawareness. For example, the processors 7008 may predictively model theeffects of recommendations on the cost and effectiveness for aparticular facility (relative to overall operations and/or variousmedical procedures). The cost and effectiveness associated with thatparticular facility can also be compared to a corresponding local regionof other facilities or any other comparable facilities.

The data sorting and prioritization module 7032 may prioritize and sortdata based on criticality (e.g., the severity of a medical eventassociated with the data, unexpectedness, suspiciousness). This sortingand prioritization may be used in conjunction with the functions of theother data analytics modules 7034 described herein to improve thecloud-based analytics and operations described herein. For example, thedata sorting and prioritization module 7032 can assign a priority to thedata analysis performed by the data collection and aggregation module7022 and patient outcome analysis modules 7028. Different prioritizationlevels can result in particular responses from the cloud 7004(corresponding to a level of urgency) such as escalation for anexpedited response, special processing, exclusion from the aggregatedmedical data databases 7011, or other suitable responses. Moreover, ifnecessary, the cloud 7004 can transmit a request (e.g., a push message)through the hub application servers for additional data fromcorresponding surgical instruments 7012. The push message can result ina notification displayed on the corresponding hubs 7006 for requestingsupporting or additional data. This push message may be required insituations in which the cloud detects a significant irregularity oroutlier and the cloud cannot determine the cause of the irregularity.The central servers 7013 may be programmed to trigger this push messagein certain significant circumstances, such as when data is determined tobe different from an expected value beyond a predetermined threshold orwhen it appears security has been comprised, for example.

Additional example details for the various functions described areprovided in the ensuing descriptions below. Each of the variousdescriptions may utilize the cloud architecture as described in FIGS. 11and 12 as one example of hardware and software implementation.

FIG. 13 illustrates a block diagram of a computer-implemented adaptivesurgical system 9060 that is configured to adaptively generate controlprogram updates for modular devices 9050, in accordance with at leastone aspect of the present disclosure. In some exemplifications, thesurgical system may include a surgical hub 9000, multiple modulardevices 9050 communicably coupled to the surgical hub 9000, and ananalytics system 9100 communicably coupled to the surgical hub 9000.Although a single surgical hub 9000 may be depicted, it should be notedthat the surgical system 9060 can include any number of surgical hubs9000, which can be connected to form a network of surgical hubs 9000that are communicably coupled to the analytics system 9010. In someexemplifications, the surgical hub 9000 may include a processor 9010coupled to a memory 9020 for executing instructions stored thereon and adata relay interface 9030 through which data is transmitted to theanalytic system 9100. In some exemplifications, the surgical hub 9000further may include a user interface 9090 having an input device 9092(e.g., a capacitive touchscreen or a keyboard; for receiving inputs froma user and an output device 9094 (e.g., a display screen) for providingoutputs to a user. Outputs can include data from a query input by theuser, suggestions for products or mixes of products to use in a givenprocedure, and/or instructions for actions to be carried out before,during, or after surgical procedures. The surgical hub 9000 further mayinclude an interface 9040 for communicably coupling the modular devices9050 to the surgical hub 9000. In one aspect, the interface 9040 mayinclude a transceiver that is communicably connectable to the modulardevice 9050 via a wireless communication protocol. The modular devices9050 can include, for example, surgical stapling and cuttinginstruments, electrosurgical instruments, ultrasonic instruments,insufflators, respirators, and display screens. In someexemplifications, the surgical hub 9000 can further be communicablycoupled to one or more patient monitoring devices 9052, such as EKGmonitors or BP monitors. In some exemplifications, the surgical hub 9000can further be communicably coupled to one or more databases 9054 orexternal computer systems, such as an EMR database of the medicalfacility at which the surgical hub 9000 is located.

When the modular devices 9050 are connected to the surgical hub 9000,the surgical hub 9000 can sense or receive perioperative data from themodular devices 9050 and then associate the received perioperative datawith surgical procedural outcome data. The perioperative data mayindicate how the modular devices 9050 were controlled during the courseof a surgical procedure. The procedural outcome data includes dataassociated with a result from the surgical procedure (or a stepthereof), which can include whether the surgical procedure (or a stepthereof) had a positive or negative outcome. For example, the outcomedata could include whether a patient suffered from postoperativecomplications from a particular procedure or whether there was leakage(e.g., bleeding or air leakage) at a particular staple or incision line.The surgical hub 9000 can obtain the surgical procedural outcome data byreceiving the data from an external source (e.g., from an EMR database9054), by directly detecting the outcome (e.g., via one of the connectedmodular devices 9050), or inferring the occurrence of the outcomesthrough a situational awareness system. For example, data regardingpostoperative complications could be retrieved from an EMR database 9054and data regarding staple or incision line leakages could be directlydetected or inferred by a situational awareness system. The surgicalprocedural outcome data can be inferred by a situational awarenesssystem from data received from a variety of data sources, including themodular devices 9050 themselves, the patient monitoring device 9052, anddie databases 9054 to which the surgical hub 9000 is connected.

The surgical hub 9000 can transmit the associated modular device 9050data and outcome data to the analytic system 9100 for processingthereon. By transmitting both the perioperative data indicating how themodular devices 9050 are controlled and the procedural outcome data, theanalytics system 9100 can correlate the different manners of controllingthe modular devices 9050 with surgical outcomes for the particularprocedure type. In some exemplifications, the analytics system 9100 mayinclude a network of analytics servers 9070 that are configured toreceive data from the surgical hubs 9000. Each of the analytics servers9070 can include a memory and a processor coupled to the memory that isexecuting instructions stored thereon to analyze the received data. Insome exemplifications, the analytics servers 9070 may be connected in adistributed computing architecture and/or utilize a cloud computingarchitecture. Based on this paired data, the analytics system 9100 canthen learn optimal or preferred operating parameters for the varioustypes of modular devices 9050, generate adjustments to the controlprograms of the modular devices 9050 in the field, and then transmit (or“push”) updates to the modular devices' 9050 control programs.

Additional detail regarding the computer-implemented interactivesurgical system 9060, including the surgical hub 9000 and variousmodular devices 9050 connectable thereto, are described in connectionwith FIGS. 5-6.

FIG. 14 provides a surgical system 6500 in accordance with the presentdisclosure and may include a surgical instrument 6502 that can be incommunication with a console 6522 or a portable device 6526 through alocal area network 6518 or a cloud network 6520 via a wired or wirelessconnection. In various aspects, the console 6522 and the portable device6526 may be any suitable computing device. The surgical instrument 6502may include a handle 6504, an adapter 6508, and a loading unit 6514. Theadapter 6508 releasably couples to the handle 6504 and the loading unit6514 releasably couples to the adapter 6508 such that the adapter 6508transmits a force from a drive shaft to the loading unit 6514. Theadapter 6508 or the loading unit 6514 may include a force gauge (notexplicitly shown) disposed therein to measure a force exerted on theloading unit 6514. The loading unit 6514 may include an end effector6530 having a first jaw 6532 and a second jaw 6534. The loading unit6514 may be an in-situ loaded or multi-firing loading unit (MFLU) thatallows a clinician to fire a plurality of fasteners multiple timeswithout requiring the loading unit 6514 to be removed from a surgicalsite to reload the loading unit 6514.

The first and second jaws 6532, 6534 may be configured to clamp tissuetherebetween, fire fasteners through the clamped tissue, and sever theclamped tissue. The first jaw 6532 may be configured to fire at leastone fastener a plurality of times, or may be configured to include areplaceable multi-fire fastener cartridge including a plurality offasteners (e.g., staples, clips, etc.) that may be fired more than onetime prior to being replaced. The second jaw 6534 may include an anvilthat deforms or otherwise secures the fasteners about tissue as thefasteners are ejected from the multi-fire fastener cartridge.

The handle 6504 may include a motor that is coupled to the drive shaftto affect rotation of the drive shaft. The handle 6504 may include acontrol interface to selectively activate the motor. The controlinterface may include buttons, switches, levers, sliders, touchscreen,and any other suitable input mechanisms or user interfaces, which can beengaged by a clinician to activate the motor.

The control interface of the handle 6504 may be in communication with acontroller 6528 of the handle 6504 to selectively activate the motor toaffect rotation of the drive shafts. The controller 6528 may be disposedwithin the handle 6504 and is configured to receive input from thecontrol interface and adapter data from the adapter 6508 or loading unitdata from the loading unit 6514. The controller 6528 may analyze theinput from the control interface and the data received from the adapter6508 and/or loading unit 6514 to selectively activate the motor. Thehandle 6504 may also include a display that is viewable by a clinicianduring use of the handle 6504. The display may be configured to displayportions of the adapter or loading unit data before, during, or afterfiring of the instrument 6502.

The adapter 6508 may include an adapter identification device 6510disposed therein and the loading unit 6514 includes a loading unitidentification device 6516 disposed therein. The adapter identificationdevice 6510 may be in communication with the controller 6528, and theloading unit identification device 6516 may be in communication with thecontroller 6528. It will be appreciated that the loading unitidentification device 6516 may be in communication with the adapteridentification device 6510, which relays or passes communication fromthe loading unit identification device 6516 to the controller 6528.

The adapter 6508 may also include a plurality of sensors 6512 (oneshown) disposed thereabout to detect various conditions of the adapter6508 or of the environment (e.g., if the adapter 6508 is connected to aloading unit, if the adapter 6508 is connected to a handle, if the driveshafts are rotating, the torque of the drive shafts, the strain of thedrive shafts, the temperature within the adapter 6508, a number offirings of the adapter 6508, a peak force of the adapter 6508 duringfiring, a total amount of force applied to the adapter 6508, a peakretraction force of the adapter 6508, a number of pauses of the adapter6508 during firing, etc.). The plurality of sensors 6512 may provide aninput to the adapter identification device 6510 in the form of datasignals. The data signals of the plurality of sensors 6512 may be storedwithin, or be used to update the adapter data stored within, the adapteridentification device 6510. The data signals of the plurality of sensors6512 may be analog or digital. The plurality of sensors 6512 may includea force gauge to measure a force exerted on the loading unit 6514 duringfiring.

The handle 6504 and the adapter 6508 can be configured to interconnectthe adapter identification device 6510 and the loading unitidentification device 6516 with the controller 6528 via an electricalinterface. The electrical interface may be a direct electrical interface(i.e., include electrical contacts that engage one another to transmitenergy and signals therebetween). Additionally or alternatively, theelectrical interface may be a non-contact electrical interface towirelessly transmit energy and signals therebetween (e.g., inductivelytransfer). It is also contemplated that the adapter identificationdevice 6510 and the controller 6528 may be in wireless communicationwith one another via a wireless connection separate from the electricalinterface.

The handle 6504 may include a transmitter 6506 that is configured totransmit instrument data from the controller 6528 to other components ofthe system 6500 (e.g., the LAN 6518, the loud 6520, the console 6522, orthe portable device 6526). The transmitter 6506 also may receive data(e.g., cartridge data, loading unit data, or adapter data) from theother components of the system 6500. For example, the controller 6528may transmit instrument data including a serial number of an attachedadapter (e.g., adapter 6508) attached to the handle 6504, a serialnumber of a loading unit (e.g., loading unit 6514) attached to theadapter, and a serial number of a multi-fire fastener cartridge (e.g.,multi-fire fastener cartridge), loaded into the loading unit, to theconsole 6528. Thereafter, the console 6522 may transmit data (e.g.,cartridge data, loading unit data, or adapter data) associated with theattached cartridge, loading unit, and adapter, respectively, back to thecontroller 6528. The controller 6528 can display messages on the localinstrument display or transmit the message, via transmitter 6506, to theconsole 6522 or the portable device 6526 to display the message on thedisplay 6524 or portable device screen, respectively.

FIG. 15A illustrates an example flow for determining a mode of operationand operating in the determined mode. The computer-implementedinteractive surgical system and/or components and/or subsystems of thecomputer-implemented interactive surgical system may be configured to beupdated. Such updates may include the inclusions of features andbenefits that were not available to the user before the update. Theseupdates may be established by any method of hardware, firmware, andsoftware updates suitable for introducing the feature to the user. Forexample, replaceable; swappable (e.g., hot swappable) hardwarecomponents, flashable firmware devices, and updatable software systemsmay be used to update computer-implemented interactive surgical systemand/or components and/or subsystems of the computer-implementedinteractive surgical system.

The updates may be conditioned on any suitable criterion or set ofcriteria. For example, an update may be conditioned on one or morehardware capabilities of the system, such as processing capability,bandwidth, resolution, and the like. For example, the update may beconditioned on one or more software aspects, such as a purchase ofcertain software code. For example, the update may be conditioned on apurchased service tier. The service tier may represent a feature and/ora set of features the user is entitled to use in connection with thecomputer-implemented interactive surgical system. The service tier maybe determined by a license code, an e-commerce server authenticationinteraction, a hardware key, a username/password combination, abiometric authentication interaction, a public: private key exchangeinteraction, or the like.

At 10704, a system/device parameter may be identified. The system/deviceparameter may be any element or set of elements on which an update inconditioned. For example, the computer-implemented interactive surgicalsystem may detect a certain bandwidth of communication between a modulardevice and a surgical hub. For example, the computer-implementedinteractive surgical system may detect an indication of the purchase ofcertain service tier.

At 10708, a mode of operation may be determined based on the identifiedsystem/device parameter. This determination may be made by a processthat maps system/device parameters to modes of operation. The processmay be a manual and/or an automated process. The process may be theresult of local computation and/or remote computation. For example, aclient/server interaction may be used to determine the mode of operationbased on the on the identified system/device parameter. For example,local software and/or locally embedded firmware may be used to determinethe mode of operation based on the identified system/device parameter.For example, a hardware key, such as a secure microprocessor forexample, may be used to determine the mode of operation based on theidentified system/device parameter.

At 10710, operation may proceed in accordance with the determined modeof operation. For example, a system or device may proceed to operate ina default mode of operation. For example, a system or device may proceedto operate in an alternate mode of operation. The mode of operation maybe directed by control hardware, firmware, and/or software alreadyresident in the system or device. The mode of operation may be directedby control hardware, firmware, and/or software newly installed/updated.

FIG. 15B illustrates an example functional block diagram for changing amode of operation. An upgradeable element 10714 may include aninitialization component 10716. The initialization component 10716 mayinclude any hardware, firmware, and/or software suitable determining amode of operation. For example, the initialization component 10716 maybe portion of a system or device start-up procedure. The initializationcomponent 10716 may engage in an interaction to determine a mode ofoperation for the upgradeable element 10714. For example, theinitialization component 10716 may interact with a user 10730, anexternal resource 10732, and/or a local resource 10718 for example. Forexample, the initialization component 10716 may receive a licensing keyfrom the user 10730 to determine a mode of operation. The initializationcomponent 10716 may query an external resource 10732, such as a serverfor example, with a serial number of the upgradable device 10714 todetermine a mode of operation. For example, the initialization component10716 may query a local resource 10718, such as a local query todetermine an amount of available bandwidth and/or a local query of ahardware key for example, to determine a mode of operation.

The upgradeable element 10714 may include one or more operationcomponents 10720, 10722, 10726, 10728 and an operational pointer 10724.The initialization component 10716 may direct the operational pointer10724 to direct the operation of the upgradable element 10741 to theoperation component 10720, 10722, 10726, 10728 that corresponds with thedetermined mode of operation. The initialization component 10716 maydirect the operational pointer 10724 to direct the operation of theupgradable element to a default operation component 10720. For example,the default operation component 10720 may be selected on the conditionof no other alternate mode of operation being determined. For example,the default operation component 10720 may be selected on the conditionof a failure of the initialization component and/or interaction failure.The initialization component 10716 may direct the operational pointer10724 to direct the operation of the upgradable element 10714 to aresident operation component 10722. For example, certain features may beresident in the upgradable component 10714 but require activation to beput into operation. The initialization component 10716 may direct theoperational pointer 10724 to direct the operation of the upgradableelement 10714 to install a new operation component 10728 and/or a newinstalled operation component 10726. For example, new software and/orfirmware may be downloaded. The new software and or firmware may containcode to enable the features represented by the selected mode ofoperation. For example, a new hardware component may be installed toenable the selected mode of operation.

FIG. 16 is a perspective view of a powered surgical stapling system.FIG. 16 illustrates the surgical instrument 1010 (e.g., an endocutter)that includes an interchangeable shaft assembly 1200 operably coupled toa housing 1012. FIG. 17 is a perspective view of an interchangeablesurgical shaft assembly of the powered surgical stapling system of FIG.16. FIG. 17 illustrates the interchangeable shaft assembly 1200 detachedfrom the housing 1012 or handle 1014. FIG. 18 is an exploded assemblyview of portions of a handle assembly of the powered surgical staplingsystem of FIG. 16. As can be seen in FIG. 18, the handle 1014 maycomprise a pair of interconnectable handle housing segments 1016 and1018 that may be interconnected by screws, snap features, adhesive, etc.In the illustrated arrangement, the handle housing segments 1016, 1018cooperate to form a pistol grip portion 1019. FIGS. 16 and 18 depict amotor-driven surgical cutting and fastening instrument 1010 that may ormay not be reused. In the illustrated embodiment, the instrument 1010includes a previous housing 1012 that comprises a handle 1014 that isconfigured to be grasped, manipulated and actuated by the clinician. Thehousing 1012 can be configured for operable attachment to aninterchangeable shaft assembly 1200 that has a surgical end effector1300 operably coupled thereto that can be configured to perform one ormore surgical tasks or procedures. As the present Detailed Descriptionproceeds, it will be understood that the various forms ofinterchangeable shaft assemblies disclosed herein may also beeffectively employed in connection with robotically-controlled surgicalsystems. Thus, the term “housing” may also encompass a housing orsimilar portion of a robotic system that houses or otherwise operablysupports at least one drive system that is configured to generate andapply at least one control motion which could be used to actuate theinterchangeable shaft assemblies disclosed herein and their respectiveequivalents. In addition, various components may be “housed” orcontained in the housing or various components may be “associated with”a housing. In such instances, the components may not be contained withinthe housing or supported directly by the housing. The term “frame” mayrefer to a portion of a handheld surgical instrument. The term “frame”may also represent a portion of a robotically controlled surgicalinstrument and/or a portion of the robotic system that may be used tooperably control a surgical instrument. For example, the interchangeableshaft assemblies disclosed herein may be employed with various roboticsystems, instruments, components and methods disclosed in which ishereby incorporated by reference herein in its entirety.

The previous housing 1012 depicted in FIG. 16 is shown in connectionwith an interchangeable shaft assembly 1200 (FIGS. 17, 19 and 20) thatincludes an end effector 1300 that comprises a surgical cutting andfastening device that is configured to operably support a surgicalstaple cartridge 4000 therein. The housing 1012 may be configured foruse in connection with interchangeable shaft assemblies that include endeffectors that are adapted to support different sizes and types ofstaple cartridges, have different shaft lengths, sizes, and types, etc.In addition, the housing 1012 may also be effectively employed with avariety of other interchangeable shaft assemblies including thoseassemblies that are configured to apply other motions and forms ofenergy such as, for example, radio frequency (RF) energy, ultrasonicenergy and/or motion to end effector arrangements adapted for use inconnection with various surgical applications and procedures.Furthermore, the end effectors, shaft assemblies, handles, surgicalinstruments, and/or surgical instrument systems can utilize any suitablefastener that can be gripped and manipulated by the clinician. As willbe discussed in further detail below, the handle 1014 operably supportsa plurality of drive systems therein that are configured to generate andapply various control motions to corresponding portions of theinterchangeable shaft assembly that is operably attached thereto.

Referring now to FIG. 18, the handle 1014 may further include a frame1020 that operably supports a plurality of drive systems. For example,the frame 1020 can operably support a “first” or closure drive system,generally designated as 1030, which may be employed to apply closing andopening motions to the interchangeable shaft assembly 1200 that isoperably attached or coupled thereto. In at least one form, the closuredrive system 1030 may include an actuator in the form of a closuretrigger 1032 that is pivotally supported by the frame 1020. Morespecifically, as illustrated in FIG. 18, the closure trigger 1032 can bepivotally coupled to the handle 1014 by a pin 1033. Such arrangementenables the closure trigger 1032 to be manipulated by a clinician suchthat when the clinician grips the pistol grip portion 1019 of the handle1014, the closure trigger 1032 may be easily pivoted from a starting or“unactuated” position to an “actuated” position and more particular) toa fully compressed or fully actuated position. The closure trigger 1032may be biased into the unactuated position by spring or other biasingarrangement (not shown). In various forms, the closure drive system 1030further includes a closure linkage assembly 1034 that can be pivotallycoupled to the closure trigger 1032. As can be seen in FIG. 18, theclosure linkage assembly 1034 may include a first closure link 1036 anda second closure link 1038 that are pivotally coupled to the closuretrigger 1032 by a pin 1035. The second closure link 1038 may also bereferred to herein as an “attachment member” and include a transverseattachment pin 1037.

Still referring to FIG. 18, it can be observed that the first closurelink 1036 may have a locking wall or end 1039 thereon that is configuredto cooperate with a closure release assembly 1060 that is pivotallycoupled to the frame 1020. In at least one form, the closure releaseassembly 1060 may comprise a release button assembly 1062 that has adistally protruding locking pawl 1064 formed thereon. The release buttonassembly 1062 may be pivoted in a counterclockwise direction by arelease spring (not shown). As the clinician depresses the closuretrigger 1032 from its unactuated position towards the pistol gripportion 1019 of the handle 1014, the first closure link 1036 pivotsupward to a point wherein the locking pawl 1064 drops into retainingengagement with the locking wall 1039 on the first closure link 1036thereby preventing the closure trigger 1032 from returning to theunactuated position. Thus, the closure release assembly 1060 may serveto lock the closure trigger 1032 in the fully actuated position. Whenthe clinician desires to unlock the closure trigger 1032 to permit it tobe biased to the =actuated position, the clinician may simply pivot theclosure release button assembly 1062 such that the locking pawl 1064 ismoved out of engagement with the locking wall 1039 on the first closurelink 1036. When the locking pawl 1064 has been moved out of engagementwith the first closure link 1036, the closure trigger 1032 may pivotback to the unactuated position. Other closure trigger locking andrelease arrangements may also be employed.

An arm 1061 may extend from the closure release button 1062. A magneticelement 1063, such as a permanent magnet, for example, may be mounted tothe arm 1061. When the closure release button 1062 is rotated from itsfirst position to its second position, the magnetic element 1063 canmove toward a circuit board 1100. The circuit board 1100 can include atleast one sensor that is configured to detect the movement of themagnetic element 1063. In at least one embodiment, for example, a “HallEffect” sensor (not shown) can be mounted to the bottom surface of thecircuit board 1100. The Hall Effect sensor can be configured to detectchanges in a magnetic field surrounding the Hall Effect sensor caused bythe movement of the magnetic element 1063. The Hall Effect sensor can bein signal communication with a microcontroller, for example, which candetermine whether the closure release button 1062 is in its firstposition, which is associated with the unactuated position of theclosure trigger 1032 and the open configuration of the end effector, itssecond position, which is associated with the actuated position of theclosure trigger 1032 and the closed configuration of the end effector,and/or any position between the first position and the second position.

In at least one form, the handle 1014 and the frame 1020 may operablysupport another drive system referred to herein as a firing drive system1080 that is configured to apply firing motions to correspondingportions of the interchangeable shaft assembly attached thereto. Thefiring drive system 1080 may also be referred to herein as a “seconddrive system”. The firing drive system 1080 may employ an electric motor1082 that may be located in the pistol grip portion 1019 of the handle1014. In various forms, the motor 1082 may be a DC brushed driving motorhaving a maximum rotation of, approximately, 25,000 RPM, for example. Inother arrangements, the motor may include a brushless motor, a cordlessmotor, a synchronous motor, a stepper motor, or any other suitableelectric motor. The motor 1082 may be powered by a power source 1090that in one form may comprise a removable power pack 1092. As can beseen in FIG. 3, for example, the power pack 1092 may comprise a proximalhousing portion 1094 that is configured for attachment to a distalhousing portion 1096. The proximal housing portion 1094 and the distalhousing portion 1096 may be configured to operably support a pluralityof batteries 1098 therein. Batteries 1098 may each comprise, forexample, a Lithium Ion (“LI”) or other suitable battery. The distalhousing portion 1096 may be configured for removable operable attachmentto the circuit board 1100 which may also be operably coupled to themotor 1082. A number of batteries 1098 may be connected in series may beused as the power source for the surgical instrument 1010. In addition,the power source 1090 may be replaceable and/or rechargeable.

As outlined above with respect to other various forms, the electricmotor 1082 can include a rotatable shaft (not shown) that operablyinterfaces with a gear reducer assembly 1084 that is mounted in meshingengagement with a with a set, or rack, of drive teeth 1122 on alongitudinally-movable drive member 1120. In use, a voltage polarityprovided by the power source 1090 can operate the electric motor 1082 ina clockwise direction wherein the voltage polarity applied to theelectric motor by the battery can be reversed in order to operate theelectric motor 1082 in a counter-clockwise direction. When the electricmotor 1082 is rotated in one direction, the drive member 1120 will beaxially driven in the distal direction “DD”. When the motor 82 is drivenin the opposite rotary direction, the drive member 1120 will be axiallydriven in a proximal direction “PD”. The handle 1014 can include aswitch which can be configured to reverse the polarity applied to theelectric motor 1082 by the power source 1090. As with the other formsdescribed herein, the handle 1014 can also include a sensor that isconfigured to detect the position of the drive member 1120 and/or thedirection in which the drive member 1120 is being moved.

Actuation of the motor 1082 can be controlled by a firing trigger 1130that is pivotally supported on the handle 1014. The firing trigger 1130may be pivoted between an unactuated position and an actuated position.The firing trigger 1130 may be biased into the unactuated position by aspring 1132 or other biasing arrangement such that when the clinicianreleases the firing trigger 1130, it may be pivoted or otherwisereturned to the unactuated position by the spring 1132 or biasingarrangement. In at least one form, the firing trigger 1130 can bepositioned “outboard” of the closure trigger 1032 as was discussedabove. In at least one form, a firing trigger safety button 1134 may bepivotally mounted to the closure trigger 1032 by the pin 1035. Thesafety button 1134 may be positioned between the firing trigger 1130 andthe closure trigger 1032 and have a pivot arm 1136 protruding therefrom.When the closure trigger 1032 is in the unactuated position, the safetybutton 1134 can be contained in the handle 1014 where the cliniciancannot readily access it and move it between a safety positionpreventing actuation of the firing trigger 1130 and a firing positionwherein the firing trigger 1130 may be fired. As the clinician depressesthe closure trigger 1032, the safety button 1134 and the firing trigger1130 pivot down wherein they can then be manipulated by the clinician.

As indicated above, in at least one form, the longitudinally movabledrive member 1120 has a rack of teeth 1122 formed thereon for meshingengagement with a corresponding drive gear 1086 of the gear reducerassembly 1084. At least one form also includes a manually-actuatable“bailout” assembly 1140 that may be configured to enable the clinicianto manually retract the longitudinally movable drive member 1120 shouldthe motor 1082 become disabled. The bailout assembly 1140 may include alever or bailout handle assembly 1142 that is configured to be manuallypivoted into ratcheting engagement with teeth 1124 also provided in thedrive member 1120. Thus, the clinician can manually retract the drivemember 1120 by using the bailout handle assembly 1142 to ratchet thedrive member 1120 in the proximal direction “PD”. U.S. Pat. No.8,608,045, entitled “POWERED SURGICAL CUTTING AND STAPLING APPARATUSWITH MANUALLY RETRACTABLE FIRING SYSTEM.” discloses bailout arrangementsand other components, arrangements and systems that may also be employedwith the various instruments disclosed herein. U.S. Pat. No. 8,608,045is hereby incorporated by reference herein in its entirety.

Turning now to FIGS. 17 and 20, the interchangeable shaft assembly 1200may include a surgical end effector 1300 that comprises an elongatechannel 1310 that can be configured to operably support a staplecartridge 4000 therein. The end effector 1300 may further include ananvil 2000 that is pivotally supported relative to the elongate channel1310. The interchangeable shaft assembly 1200 may further include anarticulation point 3020 and an articulation lock 2140 which can beconfigured to releasably hold the end effector 1300 in a desiredposition relative to a shaft axis SA. Examples of various features of atleast one form of the end effector 1300, the articulation point 3020 andarticulation locks may be found in U.S. patent application Ser. No.13/803,086, filed Mar. 14, 2013, entitled “ARTICULATABLE SURGICALINSTRUMENT COMPRISING AN ARTICULATION LOCK,” now U.S. Patent ApplicationPublication No. 2014/0263541, which is hereby incorporated by referenceherein in its entirety. FIG. 19 is an exploded assembly view of theinterchangeable surgical shaft assembly of FIG. 17. As can be seen inFIG. 19, the interchangeable shaft assembly 1200 can further include aproximal housing or nozzle 1201 comprised of nozzle portions 1202 and1203.

The interchangeable shaft assembly 1200 can further include a closuresystem or closure member assembly 3000 which can be utilized to closeand/or open the anvil 2000 of the end effector 1300. The shaft assembly1200 can include a spine 1210 that may be configured to, one, slidablysupport a firing member therein and, two, slidably support the closuremember assembly 3000 which extends around the spine 1210. FIG. 20 showspartial exploded assembly view of a portion of the interchangeablesurgical shaft assembly of FIG. 19. As can be seen in FIG. 20, a distalend 1212 of spine 1210 terminates in an upper lug mount feature 1270 andin a lower lug mount feature 1280. The upper lug mount feature 1270 canbe formed with a lug slot 1272 therein that is adapted to mountinglysupport an upper mounting link 1274 therein. Similarly, the lower lugmount feature 1280 is formed with a lug slot 1282 therein that may beadapted to mountingly support a lower mounting link 1284 therein. Theupper mounting link 1274 may include a pivot socket 1276 therein thatcan be adapted to rotatably receive therein a pivot pin 1292 that isformed on a channel cap or anvil retainer 1290 that is attached to aproximal end portion 1312 of the elongate channel 1310. The lowermounting link 1284 may include lower pivot pin 1286 that adapted to bereceived within a pivot hole 1314 formed in the proximal end portion1312 of the elongate channel 1310. See FIG. 20. The lower pivot pin 1286can be vertically aligned with the pivot socket 1276 to define anarticulation axis AA about which the surgical end effector 1300 mayarticulate relative to the shaft axis SA. See FIG. 17.

In the illustrated example, the surgical end effector 1300 can beselectively articulatable about the articulation axis AA by anarticulation system 2100. In one form, the articulation system 2100 mayinclude proximal articulation driver 2102 that can be pivotally coupledto an articulation link 2120. As can be most particularly seen in FIG.20, an offset attachment lug 2114 may be formed on a distal end 2110 ofthe proximal articulation driver 2102. A pivot hole 2116 can be formedin the offset attachment lug 2114 and is configured to pivotally receivetherein a proximal link pin 2124 formed on the proximal end 2122 of thearticulation link 2120. A distal end 2126 of the articulation link 2120may include a pivot hole 2128 that is configured to pivotally receivetherein a channel pin 1317 formed on the proximal end portion 1312 ofthe elongate channel 1310. Thus, axial movement of proximal articulationdriver 2102 will thereby apply articulation motions to the elongatechannel 1310 to thereby cause the surgical end effector 1300 toarticulate about the articulation axis AA relative to the spine 1210.Further details concerning the construction and operation of thearticulation system 2100 may be found in various references incorporatedby reference herein including U.S. patent application Ser. No.15/635,631, filed Jun. 28, 2017, entitled “SURGICAL INSTRUMENT WITHAXIALLY MOVABLE CLOSURE MEMBER,” now U.S. Patent Application PublicationNo. 2019/0000464, which is hereby incorporated by reference herein inits entirety In various circumstances, the proximal articulation driver2102 can be held in position by an articulation lock 2140 when theproximal articulation driver 2102 is not being moved in the proximal ordistal directions. Additional details regarding an example of anarticulation lock 2140 may be found in U.S. Patent ApplicationPublication No. 2019/0000464, as well as in other referencesincorporated by reference herein.

In various circumstances, the spine 1210 can comprise a proximal end1211 which can be rotatable supported in a chassis 1240. In onearrangement, for example, the proximal end 1211 of the spine 1210 has athread 1214 formed thereon for threaded attachment to a spine bearing1216 configured to be supported within the chassis 1240. See FIG. 19.Such an arrangement facilitates rotatable attachment of the spine 1210to the chassis 1240 such that the spine 1210 may be selectively rotatedabout a shaft axis SA relative to the chassis 1240.

Referring primarily to FIG. 19, the interchangeable shaft assembly 1200may include a closure shuttle 1250 that is slidably supported within thechassis 1240 such that it may be axially moved relative thereto. Theclosure shuttle 1250 may include a pair of proximally protruding hooks1252 that may be configured for attachment to the attachment pin 1037(FIG. 3) that can be attached to the second closure link 1038 as will bediscussed in further detail below. In at least one example, the closuremember assembly 3000 can comprise a proximal closure member segment 3010that may have a proximal end 3012 that may be coupled to the closureshuttle 1250 for relative rotation thereto. For example, a U-shapedconnector 1263 can be inserted into an annular slot 3014 in the proximalend 3012 of the proximal closure member segment 3010 and can be retainedwithin vertical slots 1253 in the closure shuttle 1250. Such anarrangement may serve to attach the proximal closure member segment 3010to the closure shuttle 1250 for axial travel therewith while enablingthe proximal closure member segment 3010 to rotate relative to theclosure shuttle 1250 about the shaft axis SA. A closure spring 1268 maybe journaled on the proximal closure member segment 3010 and serves tobias the proximal closure member segment 3010 in the proximal direction“PD” which can serve to pivot the closure trigger 1032 into theunactuated position when the shaft assembly is operably coupled to thehandle 1014.

In at least one form, the interchangeable shaft assembly 1200 mayfurther include an articulation joint 3020. Other interchangeable shaftassemblies, however, may not be capable of articulation. As can be seenin FIG. 20, for example, a distal closure member or distal closure tubesegment 3030 may be coupled to the distal end of the proximal closuremember segment 3010. The articulation joint 3020 includes a double pivotclosure sleeve assembly 3022. According to various forms, the doublepivot closure sleeve assembly 3022 includes an end effector closure tube3050 having upper and lower distally projecting tangs 3052, 3054. Anupper double pivot link 3056 includes upwardly projecting distal andproximal pivot pins that engage respectively an upper distal pin hole inthe upper proximally projecting tang 3052 and an upper proximal pin holein an upper distally projecting tang 3032 on the distal closure tubesegment 3030. A lower double pivot link 3058 includes upwardlyprojecting distal and proximal pivot pins that engage respectively alower distal pin hole in the lower proximally projecting tang 3054 and alower proximal pin hole in the lower distally projecting tang 3034. SeeFIGS. 19 and 20. As will be discussed in further detail below, theclosure member assembly 3000 is translated distally (direction “DD”) toclose the anvil 2000, for example, in response to the actuation of theclosure trigger 1032. The anvil 2000 is opened by proximally translatingthe closure member assembly 3000 which causes the end effector closuresleeve to interact with the anvil 2000 and pivot it to an open position.

As was also indicated above, the interchangeable shaft assembly 1200further includes a firing member 1900 that is supported for axial travelwithin the spine 1210. The firing member 1900 includes an intermediatefiring shaft portion 1222 that is configured for attachment to a distalcutting portion or knife bar 1910. The intermediate firing shaft portion1222 may include a longitudinal slot 1223 in the distal end thereofwhich can be configured to receive a tab 1912 on the proximal end of thedistal knife bar 1910. The longitudinal slot 1223 and the proximal endtab 1912 can be sized and configured to permit relative movementtherebetween and can comprise a slip joint 1914. The slip joint 1914 canpermit the intermediate firing shaft portion 1222 of the firing member1900 to be moved to articulate the end effector 1300 without moving, orat least substantially moving, the knife bar 1910. Once the end effector1300 has been suitably oriented, the intermediate firing shaft portion1222 can be advanced distally until a proximal sidewall of thelongitudinal slot 1223 comes into contact with the tab 1912 in order toadvance the knife bar 1910 and tee the staple cartridge 4000 positionedwithin the channel 1310. The knife bar 1910 can include a knife portion1920 that can include a blade or tissue cutting edge 1922 and includesan upper anvil engagement tab 1924 and lower channel engagement tabs1926. Various firing member configurations and operations can bedisclosed in various other references incorporated herein by reference.

As can be seen in FIG. 19, the shaft assembly 1200 further may include aswitch drum 1500 that can be rotatable received on proximal closuremember segment 3010. The switch drum 1500 may comprise a hollow shaftsegment 1502 that may have a shaft boss formed thereon for receive anoutwardly protruding actuation pin therein. In various circumstances,the actuation pin may extend through a longitudinal slot provided in thelock sleeve to facilitate axial movement of the lock sleeve when it isengaged with the articulation driver. A rotary torsion spring 1420 canbe configured to engage the boss on the switch drum 1500 and a portionof the nozzle housing 1203 to apply a biasing force to the switch drum1500. The switch drum 1500 can further comprise at least partiallycircumferential openings 1506 defined therein which can be configured toreceive circumferential mounts extending from the nozzle portions 1202,1203 and permit relative rotation, but not translation, between theswitch drum 1500 and the nozzle 1201. The mounts may also extend throughopenings 3011 in the proximal closure member segment 3010 to be seatedin recesses 1219 in the spine 1210. Rotation of the switch drum 1500about the shaft axis SA will ultimately result in the rotation of theactuation pin and the lock sleeve between its engaged and disengagedpositions. In one arrangement, the rotation of the switch drum 1500 maybe linked to the axial advancement of the closure tube or closuremember. Thus, in essence, actuation of the closure system may operablyengage and disengage the articulation drive system with the firing drivesystem in the various manners described in further detail in U.S. patentapplication Ser. No. 13/803,086, entitled ARTICULATABLE SURGICALINSTRUMENT COMPRISING AN ARTICULATION LOCK, now U.S. Patent ApplicationPublication No. 2014/0263541, and U.S. Pat. No. 9,913,642, entitled“SURGICAL INSTRUMENT COMPRISING A SENSOR SYSTEM,” which is herebyincorporated by reference herein in its entirety. For example, when theclosure tube is in its proximal-most position corresponding to a “jawsopen” position, the closure member segment 3010 will have positioned theswitch drum 1500 so as to link the articulation system with the firingdrive system. When, the closure tube has been moved to its distalposition corresponding to a “jaws closed” position, the closure tube hasrotated the switch drum 1500 to a position wherein the articulationsystem is delinked from the fining drive system.

As also illustrated in FIG. 19, the shaft assembly 1200 can comprise aslip ring assembly 1600 which can be configured to conduct electricalpower to and/or from the end effector 1300 and/or communicate signals toand; or from the end effector 1300, for example. The slip ring assembly1600 can comprise a proximal connector flange 1604 that can be mountedto a chassis flange 1242 that extends from the chassis 1240 and a distalconnector flange that is positioned within a slot defined in the shafthousings. The proximal connector flange 1604 can comprise a first faceand the distal connector flange can comprise a second face which ispositioned adjacent to and movable relative to the first face. Thedistal connector flange can rotate relative to the proximal connectorflange 1604 about the shaft axis SA. The proximal connector flange 1604can comprise a plurality of concentric, or at least substantiallyconcentric, conductors defined in the first face thereof. A connectorcan be mounted on the proximal side of the connector flange and may havea plurality of contacts wherein each contact corresponds to and is inelectrical contact with one of the conductors. Such an arrangement maypermit relative rotation between the proximal connector flange 1604 andthe distal connector flange while maintaining electrical contacttherebetween. The proximal connector flange 1604 can include anelectrical connector 1606 which can place the conductors in signalcommunication with a shaft circuit board 1610 mounted to the shaftchassis 1240, fox example. In at least one instance, a wiring harnesscomprising a plurality of conductors can extend between the electricalconnector 1606 and the shaft circuit board 1610. The electricalconnector 1606 may extend proximally through a connector opening 1243defined in the chassis flange 1242. See FIG. 19. Further detailsregarding slip ring assembly 1600 may be found, for example, in U.S.patent application Ser. No. 13/803,086, entitled “ARTICULATABLE SURGICALINSTRUMENT COMPRISING AN ARTICULATION LOCK,” now U.S. Patent ApplicationPublication No. 2014/0263541, U.S. patent application Ser. No.13/800,067, entitled “STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM,”filed on Mar. 13, 2013, now U.S. Patent Application Publication No.2014/0263552, which is hereby incorporated by reference herein in itsentirety, and U.S. Pat. No. 9,345,481, entitled “STAPLE CARTRIDGE TISSUETHICKNESS SENSOR SYSTEM,” which is hereby incorporated by referenceherein in its entirety.

As discussed above, the shaft assembly 1200 can include a proximalportion which is fixably mounted to the handle 1014 and a distal portionwhich is rotatable about a longitudinal axis. The rotatable distal shaftportion can be rotated relative to the proximal portion about the slipring assembly 1600, as discussed above. The distal connector flange ofthe slip ring assembly 1600 can be positioned within the rotatabledistal shaft portion. Moreover, further to the above, the switch drum1500 can also be positioned within the rotatable distal shaft portion.When the rotatable distal shaft portion is rotated, the distal connectorflange and the switch drum 1500 can be rotated synchronously with oneanother. In addition, the switch drum 1500 can be rotated between afirst position and a second position relative to the distal connectorflange. When the switch drum 1500 is in its first position, thearticulation drive system may be operably disengaged from the firingdrive system and, thus, the operation of the firing drive system may notarticulate the end effector 1300 of the shaft assembly 1200. When theswitch drum 1500 is in its second position, the articulation drivesystem may be operably engaged with the firing drive system and, thus,the operation of the fining drive system may articulate the end effector1300 of the shaft assembly 1200. When the switch drum 1500 is movedbetween its first position and its second position, the switch drum 1500is moved relative to distal connector flange. In various instances, theshaft assembly 1200 can comprise at least one sensor configured todetect the position of the switch drum 1500.

Referring again to FIG. 19, the chassis 1240 may include at least one,and preferably two, tapered attachment portions 1244 formed thereon thatare adapted to be received within corresponding dovetail slots 1702formed within a distal attachment flange portion 1700 of the frame 1020.See FIG. 18. Each dovetail slot 1702 may be tapered or, stated anotherway, be somewhat V-shaped to seatingly receive the attachment portions1244 therein. As can be further seen in FIG. 19, a shaft attachment lug1226 is formed on the proximal end of the intermediate firing shaftportion 1222. As will be discussed in further detail below, when theinterchangeable shaft assembly 1200 can be coupled to the handle 1014,the shaft attachment lug 1226 can be received in a firing shaftattachment cradle 1126 formed in a distal and 1125 of the longitudinaldrive member 1120. See FIG. 18.

Various shaft assembly embodiments can employ a latch system 1710 forremovably coupling the shaft assembly 1200 to the housing 1012 and morespecifically to the frame 1020. As can be seen in FIG. 4, for example,in at least one form, the latch system 1710 includes a lock member orlock yoke 1712 that is movably coupled to the chassis 1240. In theillustrated embodiment, for example, the lock yoke 1712 has a U-shapewith two spaced downwardly extending legs 1714. The legs 1714 each mayhave a pivot lug 1715 formed thereon that are adapted to be received incorresponding holes 1245 formed in the chassis 1240. Such arrangementmay facilitate pivotal attachment of the lock yoke 1712 to the chassis1240. The lock yoke 1712 may include two proximally protruding lock lugs1716 that are configured for releasable engagement with correspondinglock detents or grooves 1704 in the distal attachment flange portion1700 of the frame 1020. See FIG. 18. In various forms, the lock yoke1712 may be biased in the proximal direction by spring or biasing member(not shown). Actuation of the lock yoke 1712 may be accomplished by alatch button 1722 that is slidably mounted on a latch actuator assembly1720 that is mounted to the chassis 1240. The latch button 1722 may bebiased in a proximal direction relative to the lock yoke 1712. As willbe discussed in further detail below, the lock yoke 1712 may be moved toan unlocked position by biasing the latch button in the distal directionwhich also may cause the lock yoke 1712 to pivot out of retainingengagement with the distal attachment flange portion 1700 of the frame1020. When the lock yoke 1712 is in “retaining engagement” with thedistal attachment flange portion 1700 of the frame 1020, the lock lugs1716 may be retainingly seated within the corresponding lock detents orgrooves 1704 in the distal attachment flange portion 1700.

When employing an interchangeable shaft assembly that includes an endeffector of the type described herein that is adapted to cut and fastentissue, as well as other types of end effectors, it may be desirable toprevent inadvertent detachment of the interchangeable shaft assemblyfrom the housing during actuation of the end effector. For example, inuse the clinician may actuate the closure trigger 1032 to grasp andmanipulate the target tissue into a desired position. Once the targettissue may be positioned within the end effector 1300 in a desiredorientation, the clinician may then fully actuate the closure trigger1032 to close the anvil 2000 and clamp the target tissue in position forcutting and stapling. In that instance, the first drive system 1030 mayhave been fully actuated. After the target tissue has been clamped inthe end effector 1300, it may be desirable to prevent the inadvertentdetachment of the shaft assembly 1200 from the housing 1012. One form ofthe latch system 1710 may be configured to prevent such inadvertentdetachment.

As can be most particularly seen in FIG. 19, the lock yoke 1712 mayinclude at least one and preferably two lock hooks 1718 that are adaptedto contact corresponding lock lug portions 1256 that may be formed onthe closure shuttle 1250. When the closure shuttle 1250 is in anunactuated position (i.e., the first drive system 1030 is unactuated andthe anvil 2000 is open), the lock yoke 1712 may be pivoted in a distaldirection to unlock the interchangeable shaft assembly 1200 from thehousing 1012. When in that position, the lock hooks 1718 do not contactthe lock lug portions 1256 on the closure shuttle 1250. However, whenthe closure shuttle 1250 is moved to an actuated position (i.e., thefirst drive system 1030 is actuated and the anvil 2000 is in the closedposition), the lock yoke 1712 may be prevented from being pivoted to anunlocked position. Stated another way, if the clinician were to attemptto pivot the lock yoke 1712 to an unlocked position or, for example, thelock yoke 1712 may be inadvertently bumped or contacted in a manner thatmight otherwise cause it to pivot distally, the lock hooks 1718 on thelock yoke 1712 will contact the lock lug portions 1256 on the closureshuttle 1250 and prevent movement of the lock yoke 1712 to an unlockedposition.

Attachment of the interchangeable shaft assembly 1200 to the handle 1014will now be described. To commence the coupling process, the clinicianmay position the chassis 1240 of the interchangeable shaft assembly 1200above or adjacent to the distal attachment flange 1700 of the frame 1020such that the tapered attachment portions 1244 formed on the chassis1240 may be aligned with the dovetail slots 1702 in the frame 1020. Theclinician may then move the shaft assembly 1200 along an installationaxis that may be perpendicular to the shaft axis SA to seat theattachment portions 1244 in “operable engagement” with the correspondingdovetail receiving slots 1702. In doing so, the shaft attachment lug1226 on the intermediate firing shaft portion 1222 will also be seatedin the cradle 1126 in the longitudinally movable drive member 1120 andthe portions of the pin 1037 on the second closure link 1038 will beseated in the corresponding hooks 1252 in the closure shuttle 1250. Asused herein, the term “operable engagement” in the context of twocomponents may mean that the two components are sufficiently engagedwith each other so that upon application of an actuation motion thereto,the components may carry out their intended action, function and/orprocedure.

At least five systems of the interchangeable shaft assembly 1200 can beoperably coupled with at least five corresponding systems of the handle1014. A first system can comprise a frame system which couples and/oraligns the frame or spine of the shaft assembly 1200 with the frame 1020of the handle 1014. Another system can comprise a closure drive system1030 which can operably connect the closure trigger 1032 of the handle1014 and the closure tube 1260 and the anvil 2000 of the shaft assembly1200. As outlined above, the closure shuttle 1250 of the shaft assembly1200 can be engaged with the pin 1037 on the second closure link 1038.Another system can comprise the firing drive system 1080 which canoperably connect the firing trigger 1130 of the handle 1014 with theintermediate firing shaft portion 1222 of the shaft assembly 1200. Asoutlined above, the shaft attachment lug 1226 can be operably connectedwith the cradle 1126 of the longitudinal drive member 1120. Anothersystem can comprise an electrical system which can signal to acontroller in the handle 1014, such as microcontroller, for example,that a shaft assembly, such as shaft assembly 1200, for example, hasbeen operably engaged with the handle 1014 and/or, two, conduct powerand/or communication signals between the shaft assembly 1200 and thehandle 1014. For instance, the shaft assembly 1200 can include anelectrical connector 1810 that is operably mounted to the shaft circuitboard 1610. The electrical connector 1810 can be configured for matingengagement with a corresponding electrical connector 1800 on the handlecontrol board 1100. Further details pertaining to the circuitry andcontrol systems may be found in U.S. patent application Ser. No.13/803,086, now U.S. Patent Application Publication No. 2014/0263541,and U.S. Pat. No. 9,913,642. The fifth system may include the latchingsystem for releasably locking the shaft assembly 1200 to the handle1014.

The anvil 2000 in the illustrated example may include an anvil body 2002that terminates in an anvil mounting portion 2010. The anvil mountingportion 2010 may be movably or pivotably supported on the elongatechannel 1310 for selective pivotal travel relative thereto about a fixedanvil pivot axis PA that may be transverse to the shaft axis SA. In theillustrated arrangement, a pivot member or anvil trunnion 2012 mayextend laterally out of each lateral side of the anvil mounting portion2010 to be received in a corresponding trunnion cradle 1316 formed inthe upstanding walls 1315 of the proximal end portion 1312 of theelongate channel 1310. The anvil trunnions 2012 can be pivotallyretained in their corresponding trunnion cradle 1316 by the channel capor anvil retainer 1290. The channel cap or anvil retainer 1290 mayinclude a pair of attachment lugs that are configured to be retaininglyreceived within corresponding lug grooves or notches formed in theupstanding walls 1315 of the proximal end portion 1312 of the elongatechannel 1310. See FIG. 20.

Still referring to FIG. 20, in at least one arrangement, the distalclosure member or end effector closure tube 3050 may employ two axiallyoffset, proximal and distal positive jaw opening features 3060 and 3062.The positive jaw opening features 3060, 3062 may be configured tointeract with corresponding relieved areas and stepped portions formedon the anvil mounting portion 2010 as described in further detail inU.S. patent application Ser. No. 15/635,631, now U.S. Pat. No.10,639,037. Other jaw opening arrangements may be employed.

FIG. 21 is a perspective view of another powered surgical staplingsystem. FIG. 21 depicts a previous surgical cutting and fasteninginstrument 5010 that is configured to generate rotary drive motions foroperating a surgical end effector 5012. The endoscopic surgicalinstrument 5010 may comprise a handle 5006, a shaft 5008, and anarticulating surgical end effector 5012 pivotally connected to the shaft5008 at an articulation pivot 5014. An articulation control 5016 may beprovided adjacent to the handle 5006 to effect rotation of the endeffector 5012 about the articulation pivot 5014. It will be appreciatedthat various embodiments may include a non-pivoting end effector, andtherefore may not have an articulation pivot 5014 or articulationcontrol 5016.

The handle 5006 of the instrument 5010 may include a closure trigger5018 and a firing trigger 5020 for actuating the end effector 5012. Itwill be appreciated that instruments having end effectors directed todifferent surgical tasks may have different numbers or types of triggersor other suitable controls for operating the end effector 5012. In oneembodiment, a clinician or operator of the instrument 5010 mayarticulate the end effector 5012 relative to the shaft 5008 by utilizingthe articulation control 5016, as described in more detail in pendingU.S. Pat. No. 7,670,334, entitled “SURGICAL INSTRUMENT HAVING ANARTICULATING END EFFECTOR,” which is hereby incorporated herein byreference in its entirety. The end effector 5012 may include in thisexample, among other things, a staple channel 5022 and a pivotallytranslatable clamping member, such as an anvil 5024, which can bemaintained at a spacing that assures effective stapling and severing oftissue clamped in the end effector 5012. The handle 5006 may include apistol grip 5026 toward which the closure trigger 5018 is pivotallydrawn by the clinician to cause clamping or closing of the anvil 5024towards the staple channel 5022 of the end effector 5012 to therebyclamp tissue positioned between the anvil 5024 and channel 5022.

An example of parameters that may be gathered and communicated (e.g., asuse instructions, recommendations, and/or other information) in one ormore operating modes of a multi-mode surgical instrument is presented inFIG. 25. A variety of parameters that may be gathered and communicated(e.g., as use instructions, recommendations, and/or other information)in one or more operating modes of a multi-mode surgical instrument aredisclosed in U.S. patent application Ser. No. 16/209,416, entitled,“METHOD OF HUB COMMUNICATION, PROCESSING, DISPLAY, AND CLOUD ANALYTICS,”filed on Dec. 4, 2018, now U.S. Patent Application Publication No.2019/0206562, which is hereby incorporated herein by reference in itsentirety.

FIG. 25 illustrates example illustrative analytics. As shown, parametersgathered by the surgical hub from their paired modular devices 9050 caninclude, for example, force to fire (e.g., the force required to advancea cutting member of a surgical stapling instrument through a tissue),force to close (e.g., the force required to clamp the jaws of a surgicalstapling instrument on a tissue), the power algorithm i.e., change inpower over time of electrosurgical or ultrasonic instruments in responseto the internal states of the instrument and/or tissue conditions),tissue properties (e.g., impedance, thickness, stiffness, etc.), tissuegap (i.e., the thickness of the tissue), and closure rate (i.e., therate at which the jaws of the instrument clamped shut). It should benoted that the modular device 9050 data that is transmitted to theanalytics system 9100 (shown in FIG. 13) is not limited to a single typeof data and can include multiple different data types paired withprocedural outcome data. The procedural outcome data for a surgicalprocedure (or step thereof) can include, for example, whether there wasbleeding at the surgical site, whether there was air or fluid leakage atthe surgical site, and whether the staples of a particular staple linewere formed properly. The procedural outcome data can further include orbe associated with a positive or negative outcome, as determined by thesurgical hub 9000 or the analytics system 9100 (shown in FIG. 13), forexample. The modular device 9050 data and the procedural outcome datacorresponding to the modular device 9050 perioperative data can bepaired together or otherwise associated with each other when they areuploaded to the analytic system 9100 so that the analytics system 9100is able to recognize trends in procedural outcomes based on theunderlying data of the modular devices 9050 that produced eachparticular outcome. In other words, the analytics system 9100 canaggregate the modular device 9050 data and the procedural outcome datato search for trends or patterns in the underlying device modular data9050 that can indicate adjustments that can be made to the modulardevices' 9050 control programs.

In the depicted exemplification, the analytics system 9100 may receive9202 modular device 9050 data and procedural outcome data. Whentransmitted to the analytics system 9100, the procedural outcome datacan be associated or paired with the modular device 9050 datacorresponding to the operation of the modular device 9050 that causedthe particular procedural outcome. The modular device 9050 perioperativedata and corresponding procedural outcome data can be referred to as adata pair. The data is depicted as including a first group 9212 of dataassociated with successful procedural outcomes and a second group 9214of data associated with negative procedural outcomes. For thisparticular exemplification, a subset of the data 9212, 9214 received9202 by the analytics system 9100 is highlighted to further elucidatethe concepts discussed herein.

For a first data pair 9212 a, the modular device 9050 data can includethe force to close (FTC) over time, the force to fire (kTF) over time,the tissue type (parenchyma), the tissue conditions (the tissue is froma patient suffering from emphysema and had been subject to radiation),what number firing this was for the instrument (third), an anonymizedtime stamp (to protect patient confidentiality while still allowing theanalytics system to calculate elapsed time between firings and othersuch metrics), and an anonymized patient identifier (002). Theprocedural outcome data can include data indicating that there was nobleeding which corresponds to a successful outcome (e.g., a successfulfiring of the surgical stapling instrument). For a second data pair 9212b, the modular device 9050 data can include the wait time prior theinstrument being fired (which corresponds to the first firing of theinstrument), the FTC over time, the FTF over time (which indicates thatthere was a force spike near the end of the firing stroke), the tissuetype (1.1 mm vessel), the tissue conditions (the tissue had been subjectto radiation), what number firing this was for the instrument (first),an anonymized time stamp, and an anonymized patient identifier (002).The procedural outcome data includes data indicating that there was aleak, which corresponds to a negative outcome (i.e., a failed firing ofthe surgical stapling instrument). For a third data pair 9212 c, themodular device 9050 data may include the wait time prior the instrumentbeing fired (which corresponds to the first firing of the instrument),the FTC over time, the FTF over time, the tissue type (1.8 mm vessel),the tissue conditions (no notable conditions), what number firing thiswas for the instrument (first), an anonymized time stamp, and ananonymized patient identifier (012). The procedural outcome data mayinclude data indicating that there was a leak, which corresponds to anegative outcome (i.e., a failed firing of the surgical staplinginstrument). It should be noted again that this data is intended solelyfor illustrative purposes to assist in the understanding of the conceptsdiscussed herein and should not be interpreted to limit the data that isreceived and/or analyzed by the analytics system 9100 to generatecontrol program updates.

When the analytics system 9100 receives 9202 perioperative data from thecommunicably connected surgical hubs 9000, the analytics system 9100proceeds to aggregate and/or store the data according to the proceduretype (or a step thereof) associated with the data, the type of themodular device 9050 that generated the data, and other such categories.By collating the data accordingly, the analytics system 9100 can analyzethe data set to identify correlations between particular ways ofcontrolling each particular type of modular device 9050 and positive ornegative procedural outcomes. Based upon whether a particular manner ofcontrolling a modular device 9050 can correlate to positive or negativeprocedural outcomes, the analytics system 9100 can determine 9204whether the control program for the type of modular device 9050 shouldbe updated.

For this particular exemplification, the analytics system 9100 canperform a first analysis 9216 a of the data set by analyzing the peakFTF 9213 (e.g., the maximum FTF for each particular firing of a surgicalstapling instrument) relative to the number of firings 9211 for eachpeak FTF value. In this exemplary case, the analytics system 9100 candetermine that there is no particular correlation between the peak FTF9213 and the occurrence of positive or negative outcomes for theparticular data set. In other words, there are not distinctdistributions for the peak FTF 9213 for positive and negative outcomes.As there is no particular correlation between peak FTF 9213 and positiveor negative outcomes, the analytics system 9100 would thus determinethat a control program update to address this variable is not necessary.Further, the analytics system 9100 can perform a second analysis 9216 bof the data set by, analyzing the wait time 9215 prior to the instrumentbeing tired relative to the number of firings 9211. For this particularanalysis 9216 b, the analytics system 9100 can determine that there is adistinct negative outcome distribution 9217 and a positive outcomedistribution 9219. In this exemplary case, the negative outcomedistribution 9217 has a mean of 4 seconds and the positive outcomedistribution has a mean of 11 seconds. Thus, the analytics system 9100can determine that there is a correlation between the wait time 9215 andthe type of outcome for this surgical procedure step. Namely, thenegative outcome distribution 9217 can indicate that there is arelatively large rate of negative outcomes for wait times of 4 secondsor less. Based on this analysis 9216 b demonstrating that there can be alarge divergence between the negative outcome distribution 9217 and thepositive outcome distribution 9219, the analytics system 9100 can thendetermine 9204 that a control program update should be generated 9208.

Once the analytics system 9100 analyzes the data set and determines 9204that an adjustment to the control program of the particular moduledevice 9050 that is the subject of the data set would improve theperformance of the modular device 9050, the analytics system 9100 canthen generate 9208 a control program update accordingly. In thisexemplary case, the analytics system 9100 can determine based on theanalysis 9216 b of the data set that a control program update 9218recommending a wait time of more than 5 seconds would prevent 90% of thedistribution of the negative outcomes with a 95% confidence interval.Alternatively, the analytics system 9100 can determine based on theanalysis 9216 b of the data set that a control program update 9218recommending a wait time of more than 5 seconds would result in the rateof positive outcomes being greater than the rate of negative outcomes.The analytics system 9100 could thus determine that the particular typeof surgical instrument should wait more than 5 seconds before beingfired under the particular tissue conditions so that negative outcomesare less common than positive outcomes. Based on either or both of theseconstraints for generating 9208 a control program update that theanalytics system 9100 determines are satisfied by the analysis 92166,the analytics system 9100 can generate 9208 a control program update9218 for the surgical instrument that causes the surgical instrument,under the given circumstances, to either impose a 5 second or longerwait time before the particular surgical instrument can be tired orcauses the surgical instrument to display a warning or recommendation tothe user that indicates to the user that the user should wait at least 5seconds before firing the instrument. Various other constraints can beutilized by the analytics system 9100 in determining whether to generate9208 a control program update, such as whether a control program updatewould reduce the rate of negative outcomes by a certain percentage orwhether a control program update maximizes the rate of positiveoutcomes.

After the control program update 9218 is generated 9208, the analyticssystem 9100 then can transmit 9210 the control program update 9218 forthe appropriate type of modular devices 9050 to the surgical hubs 9000.In one exemplification, when a modular device 9050 that corresponds tothe control program update 9218 is next connected to a surgical hub 9000that has downloaded the control program update 9218, the modular device9050 then automatically downloads the update 9218. In anotherexemplification, the surgical hub 9000 controls the modular device 9050according to the control program update 9218, rather than the controlprogram update 9218 being transmitted directly to the modular device9050 itself.

In one aspect, the surgical system 9060 can be configured to push downverification of software parameters and updates if modular devices 9050are detected to be out of date in the surgical hub 9000 data stream. Inone exemplification, the analytics system 9000 can be configured totransmit a generated control program update for a particular type ofmodular device 9050 to a surgical hub 9000. In one aspect, each time amodular device 9050 connects to a surgical hub 9000, the modular device9050 determines whether there is an updated version of its controlprogram on or otherwise accessible via the surgical hub 9000. If thesurgical hub 9000 does have an updated control program (or the updatedcontrol program is otherwise available from the analytics system 9100)for the particular type of modular device 9050, then the modular device9050 downloads the control program update therefrom.

In one exemplification, any data set being transmitted to the analyticssystems 9100 includes a unique ID for the surgical hub 9000 and thecurrent version of its control program or operating system. In oneexemplification, any data set being sent to the analytics systems 9100can include a unique ID for the modular device 9050 and the currentversion of its control program or operating system. The unique ID of thesurgical hub 9000 and/or modular device 9050 being associated with theuploaded data can allow the analytics system 9100 to determine whetherthe data corresponds to the most recent version of the control program.The analytics system 9100 could, for example, elect to discount (orignore) data generated by a modular device 9050 or surgical hub 9000being controlled by an out of date control program and/or cause theupdated version of the control program to be pushed to the modulardevice 9050 or surgical hub 9000.

In one exemplification, the operating versions of the modular devices9050 the surgical hub 9000 has updated control software for could alsobe included in a surgical hub 9000 status data block that is transmittedto the analytics system 9100 on a periodic basis. If the analyticssystem 9100 identifies that the operating versions of the controlprograms of the surgical hub 9100 and/or any of the connectable modulardevices 9050 are out of date, the analytics system 9100 could push themost recent revision of the relevant control program to the surgical hub9000.

In one exemplification, the surgical hub 9000 and/or modular devices9050 can be configured to automatically download any software updates.In another exemplification, the surgical hub 9000 and/or modular devices9050 can be configured to provide a prompt for the user to ask at thenext setup step (e.g., between surgical procedures) if the user wants toupdate the out of date control program(s). In another exemplification,the surgical hub 9000 could be programmable by the user to never allowupdates or only allow updates of the modular devices 9050 and not thesurgical hub 9000 itself.

An example of cloud aggregation of data from hubs is presented in FIG.26. FIG. 26 illustrates a block diagram of a computer-implementedinteractive surgical system 5700, in accordance with at least one aspectof the present disclosure. The system 5700 can include a number ofsurgical hubs 5706 that, as described above, are able to detect andtrack data related to surgical procedures that the surgical hubs 5706(and the modular devices paired to the surgical hubs 5706) can beutilized in connection with. In one exemplification, the surgical hubs5706 can be connected to form local networks such that the data beingtracked by the surgical hubs 5706 is aggregated together across thenetwork. The networks of surgical hubs 5706 can be associated with amedical facility, for example. The data aggregated from the network ofsurgical hubs 5706 can be analyzed to provide reports on data trends orrecommendations. For example, the surgical hubs 5706 of a first medicalfacility 5704 a can be communicably connected to a first local database5708 a and the surgical hubs 5706 of a second medical facility 5704 bcan be communicably connected to a second local database 5708 b. Thenetwork of surgical hubs 5706 associated with the first medical facility5704 a can be distinct from the network of surgical hubs 5706 associatedwith the second medical facility 5704 b, such that the aggregated datafrom each network of surgical hubs 5706 corresponds to each medicalfacility 5704 a, 5704 b individually. A surgical hub 5706 or anothercomputer terminal communicably connected to the database 5708 a, 5708 bcan be configured to provide reports or recommendations based on theaggregated data associated with the respective medical facility 5704 a,5704 b. In this exemplification, the data tracked by the surgical hubs5706 can be utilized to, for example, report whether a particularincidence of a surgical procedure deviated from the average in-networktime to complete the particular procedure type.

In another exemplification, each surgical hub 5706 can be configured toupload the tracked data to the cloud 5702, which then processes andaggregates the tracked data across multiple surgical hubs 5706, networksof surgical hubs 5706, and/or medical facilities 5704 a, 5704 b that areconnected to the cloud 5702. Each surgical hub 5706 can then be utilizedto provide reports or recommendations based on the aggregated data. Inthis exemplification, the data tracked by the surgical hubs 5706 can beutilized to, for example, report whether a particular incidence of asurgical procedure deviated from the average global time to complete theparticular procedure type.

In another exemplification, each surgical hub 5706 can further beconfigured to access the cloud 5702 to compare locally tracked data toglobal data aggregated from all of the surgical hubs 5706 that arecommunicably connected to the loud 5702. Each surgical hub 5706 can beconfigured to provide reports or recommendations based on the comparisonbetween the tracked local data relative to local (i.e., in-network) orglobal norms. In this exemplification, the data tracked by the surgicalhubs 5706 can be utilized to, for example, report whether a particularincidence of a surgical procedure deviated from either the averagein-network time or the average global time to complete the particularprocedure type.

In one exemplification, each surgical hub 5706 or another computersystem local to the surgical hub 5706 can be configured to locallyaggregate the data tracked by the surgical hubs 5706, store the trackeddata, and generate reports and/or recommendations according to thetracked data in response to queries. In cases where the surgical hub5706 is connected to a medical facility network (which may includeadditional surgical hubs 5706), the surgical hub 5706 can be configuredto compare the tracked data with the bulk medical facility data. Thebulk medical facility data can include EMR data and aggregated data fromthe local network of surgical hubs 5706. In another exemplification, thecloud 5702 can be configured to aggregate the data tracked by thesurgical hubs 5706, store the tracked data, and generate reports and/orrecommendations according to the tracked data in response to queries.

Each surgical hub 5706 can provide reports regarding trends in the dataand/or provide recommendations on improving the efficiency oreffectiveness of the surgical procedures being performed. In variousexemplifications, the data trends and recommendations can be based ondata tracked by the surgical hub 5706 itself, data tracked across alocal medical facility network containing multiple surgical hubs 5706,or data tracked across a number of surgical hubs 5706 communicableconnected to a cloud 5702. The recommendations provided by the surgicalhub 5706 can describe, for example, particular surgical instruments orproduct mixes to utilize for particular surgical procedures based oncorrelations between the surgical instruments/product mixes and patientoutcomes and procedural efficiency. The reports provided by the surgicalhub 5706 can describe, for example, whether a particular surgicalprocedure was performed efficiently relative to local or global norms,whether a particular type of surgical procedure being performed at themedical facility is being performed efficiently relative to globalnorms, and the average time taken to complete a particular surgicalprocedure or step of a surgical procedure for a particular surgicalteam.

For example, the surgical hub 5706 can be utilized to perform studies ofperformance by instrument type or cartridge type for various procedures.For example, the surgical hub 5706 can be utilized to perform studies onthe performance of individual surgeons. For example, the surgical hub5706 can be utilized to perform studies on the effectiveness ofdifferent surgical procedures according to patients' characteristics ordisease states. Examples of data aggregation and analysis are describedin detail in U.S. patent application Ser. No. 15/940,668, entitled“AGGREGATION AND REPORTING OF SURGICAL HUB DATA,” filed on Mar. 29,2018, now U.S. Patent Application Publication No. 2019/0201115, which ishereby incorporated herein by reference in its entirety.

In one exemplification, each surgical hub 5706 can be configured todetermine when operating theater events occur (e.g., via a situationalawareness system) and then track the length of time spent on each event.An operating theater event can be an event that a surgical hub 5706 candetect or infer the occurrence of. An operating theater event caninclude, for example, a particular surgical procedure, a step or portionof a surgical procedure, or downtime between surgical procedures. Theoperating theater events can be categorized according to an event type,such as a type of surgical procedure being performed, so that the datafrom individual procedures can be aggregated together to four searchabledata sets.

The data tracked by the surgical hubs 5706 may be parsed to provideincreasingly detailed metrics related to surgical procedures or the useof the surgical hub 5706 for an example data set. In oneexemplification, the surgical hub 5706 can be configured to determinewhether a surgical procedure is being performed and then track both thelength of time spent between procedures (e.g., downtime) and the timespent on the procedures themselves. The surgical hub 5706 can further beconfigured to determine and track the time spent on each of theindividual steps taken by the medical personnel (e.g., surgeons, nurses,orderlies) either between or during the surgical procedures. Thesurgical hub can determine when surgical procedures or different stepsof surgical procedures are being performed via a situational awarenesssystem, which is described in further detail herein. Aggregation (e.g.,cloud aggregation) of data (e.g., from hubs) is further described inU.S. patent application Ser. No. 16/209,416, now U.S. Patent ApplicationPublication No. 20190206562.

A surgical instrument (e.g., a powered intelligent surgical stapler) mayhave a means for displaying instrument functional data to a surgicaluser. Data displayed may be based on, for example, theintercommunication capabilities of the instrument (e.g., the surgicalstapler), its accessories or consumables (e.g., cartridge(s)), and thedisplay system. Data communicated from an accessory or consumable (e.g.,a cartridge) to a user through the instrument may be or may include oneor more static cartridge functional aspects, or the accessory orconsumable (e.g., cartridge) data may be interactively combined withother data (e.g., instrument actuator or configuration data) to providea broader understanding (e.g., a more complete or a full context) ofinstrument status.

Combined data may (e.g., additionally) be aggregated, for example, todetermine tissue data or functional data from system interactions with asurgical site. Some or all (e.g., aggregated) data may be transferred toremote servers or storage. A user may be allowed to review, aggregate,or use stored data to provide insights for future uses of an instrument(e.g., a stapler). Capabilities such as instrument capabilities,features and/or user interactions allowed (e.g., and/or restricted) by asystem (e.g., a control system of an instrument) may be based on, forexample, system capacity parameters (e.g., a connectivity capability);system condition parameters (e.g., bandwidth, interference,conductivity, current load level); system authorization parameters(e.g., parameters indicating compatibility, authorized (e.g., purchased)mode/tier level of operation, authenticity); and/or control parametersprovided to an instrument by a hub or external remote sewer (e.g.,external control parameters), such as software version, revision orupdate level, subscription level, interconnectivity with anexternal/outside system, region of use, user input(s), or (e.g., secure)communication with an external database system).

An instrument may be subject to operating mode (e.g., tiered) control,which may be controlled by a hub. In some examples, a surgical hub maycontrol instrument authentication, mode of operation and communication.Information about surgical hub coordination and control is provided inU.S. patent application Ser. No. 15/940,656, entitled “SURGICAL. HUBCOORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES,”filed on Mar. 29, 2018, now U.S. Patent Application Publication No.2019/0201141, which is hereby incorporated herein by reference in itsentirety.

An instrument may initialize and may or may not be upgradedoperationally, for example, based on mode/tier control. A surgicalinstrument may be initialized, for example, upon initial or subsequentpower on or wake up. For example, a surgical instrument may wake up(e.g., be turned on, powered up), and be initialized, e.g., by pairingwith a surgical hub. A surgical instrument may initialize, for example,in an initial mode of operation (e.g., a default or entry-level mode).For example, a surgical instrument (e.g., upon being initialized) maysend initialization mode (e.g., mode 1 or tier 1) information to a hub.The surgical instrument may receive an operation mode indication fromthe hub, which may be the same or different than an initialization mode.The instrument may (e.g., depending on the operation mode) receive(e.g., from a hub) operational parameters, instructions to downloadadditional software, instructions to activate one or more functions,etc. Tiered operation (e.g., tiered access) for an instrument (e.g., anendocutter) may be controlled, for example, by a surgical hub. Forexample, a surgical instrument may receive an indication to download asoftware upgrade, e.g., to change operation from an initialization tierto another (e.g., higher or lower) tier. In an example, a surgicalinstrument may receive an indication to downgrade a mode/tier, forexample, by disabling a functionality associated with a tier (e.g., anunauthorized or unsupported tier).

A surgical device may include communication capabilities, which may bewireless. For example, an instrument may have a Bluetooth communicationarray (e.g., to communicate with a hub). A wireless connection may beestablished between an instrument and a hub, for example, duringinstrument initialization. An instrument may provide informationdescribing the instrument to a hub, such as one or more of a serialnumber, model number, and so on. An instrument may be configured withthe ability to receive information (e.g., during initialization and/orduring operation). Communication bandwidth may vary among operationalmodes. For example, an instrument may have limited bandwidth duringinitialization (e.g., to download basic information). An instrument maybe capable of and/or configurable for higher bandwidth communicationfollowing initialization and/or if elevated to another mode/tier ofoperation. A hub may provide an instrument with improved firmware and/orsoftware (e.g., communication software) to allow/support high bandwidthhigh data transfers (e.g., for real time data transfer), for example, ifthe improved communication software is not preloaded in the device atthe time of initialization. An upgrade may involve, for example,downloading and installing firmware (e.g., BIOS) and/or software. Dataaggregation capability, use of internal memory, and/or other featuresmay also vary with modes of operation.

A processor in a surgical instrument may determine whether to allow orrestrict bi directional communication. An initialized mode ofcommunication may be treated differently than an operational mode ofcommunication. For example, a first mode of operation may includeunidirectional communication (e.g., from an instrument to a hub), asecond mode of operation may include bi-directional communication, and athird mode of operation may include interactive communication (e.g.,with a local hub or other remote network portal).

FIGS. 22-24 show examples of three modes (e.g., tiers) of operation of asurgical instrument. Other examples may implement more or fewertiers/modes with the same or different operational characteristics.Various levels/modes/tiers of instrument operation may vary theavailability, access, level of use, level of interaction and/or supportfor one or more features available through an instrument, such assensors, communications, displays, storage, analyses, feedback,recommendations or advice, and so on. In examples, an instrumentprocessor may be configured to determine an operation mode, for example,based on an instrument operation control parameter (e.g., one or more ofa system capacity parameter, a system condition parameter, a systemauthorization parameter, a tiered communication mode indication receivedfrom a hub, and/or a tiered communication mode indication received froma remote server).

FIG. 22 illustrates an example surgical instrument operation mode. FIG.22 shows an example of a first mode of operation (e.g., tier I).Surgical instrument 11012 may, in an example of a first mode ofoperation, engage in unidirectional communication with surgical hub11006 and provide information fox display to display 11025. A processorin surgical instrument 11012, such as a surgical stapler, may obtaincartridge information (e.g., identification and/or authenticationinformation), cartridge authentication information, status information(e.g., firing status information), error information, and so on.Cartridge information may include, for example, cartridge identificationinformation (e.g., color, type, length, serial number, etc.), and/orcartridge authentication information (e.g., verified origin, lotinformation, etc.). Status information may include an instrument status(e.g., ready, fired, connected, etc.). Error information may includeinstrument or accessory (e.g., cartridge) errors (e.g., unable to readcartridge parameter, etc.). The surgical instrument 11012, such as asurgical stapler, may send the cartridge identification information,cartridge authentication information, status information, errorinformation, and/or other information, for example, to surgical hub11006 and/or to display 11025 (e.g., for display to a user). Informationmay be sent, for example, via a (e.g., wireless) transmitter (e.g.,Bluetooth).

In an example, first mode (e.g., tier T) information may indicate apowered endocutter was tired with a cartridge of a particular color, andthe cartridge may be associated with a serial number. Such informationmay be used to annotate a procedure, for example, to describe how thepowered endocutter was used. For example, an instrument processor may beconfigured to obtain staple cartridge information and instrument statusinformation from an end effector (e.g., for removably storing a surgicalstaple cartridge). The instrument processor may send the cartridgeinformation and the instrument status information to the surgical hub.

FIG. 23 illustrates an example surgical instrument operation mode. FIG.23 shows an example of a second mode of operation (e.g., tier II).Surgical instrument 11012 may, in an example of a second mode ofoperation, engage in bidirectional communication with surgical hub 11006and provide information to display 11025 (e.g., for display to a user).Surgical hub 11006 may communicate with remote server 11013. A secondmode of operation may build on (e.g., add capabilities or functionalityto) first mode operation.

Examples of bi-directional communication may include, for example,sensed information from the end effector (e.g., sensed parameter(s),such as tissue thickness), sensed information from the handle (e.g.,motor function, force to fire/close, etc.), usage information (e.g.,time from clamp to fire, characterization of user controlled firing,etc.), prioritization of information to display, location to displayinformation, compiled recommendations from database analysis, etc.Information may be communicated, for example, locally to/from (e.g.,within) an operating room (OR) and/or to/from one or more systemsoutside the OR (e.g., cloud-based storage, etc.).

FIG. 27 illustrates an example flow for operating in accordance withsurgical instrument operation mode(s). In an example, a surgicalinstrument may include a processor, a transmitter and at least onesensor configured to provide a sensor signal (e.g., according to aphysiological parameter of a tissue). The processor may be configured tomake one or more determinations and/or take one or more actions based onan instrument operation mode.

At 11510, a determination may be made, based on the operation mode,whether to obtain a sensed parameter from a sensor. For example, aprocessor (e.g., in a surgical instrument) may determine (e.g., based onan instrument operation mode), whether to obtain (e.g., and/or send) asensed parameter associated with a sensor signal from a sensor.

One or more sensors may sense and provide (e.g., in sensor signals)information, for example, from one or more portions (e.g., components orsubcomponents) of a surgical instrument (e.g., a handle, an endeffector, a knife, and/or a clamp). For example, a multitude of sensorsare shown (e.g., in FIG. 19) and described in a surgical instrumentcomprising an adaptive control system in U.S. patent application Ser.No. 16/361,793, entitled “SURGICAL INSTRUMENT COMPRISING AN ADAPTIVECONTROL SYSTEM,” filed Mar. 22, 2019, now U.S. Patent ApplicationPublication No. 20190314015, which is hereby incorporated herein byreference in its entirety. Sensed information from the handle mayinclude, for example, a motor function, a force to fire/close, etc.

A sensor may be configured to sense and provide a sensor signalaccording to a physiological parameter of a tissue. For example, asurgical instrument may have a tissue thickness sensing module with asensor that generates a sensor signal (e.g., tissue thickness signal)according to a physiological parameter of a tissue (e.g., tissuethickness), e.g., as shown and described with respect to FIGS. 7-15 inU.S. Pat. No. 9,345,481 and U.S. patent application Ser. No. 13/800,067,now U.S. Patent Application Publication No. 2014/0263552. In an example,a surgical instrument (e.g., an endocutter or surgical stapler) mayinclude a tissue thickness sensing module, which may be located, forexample, adjacent to the distal end of a staple cartridge. A tissuethickness sensing module may comprise a sensor and a controller. Asensor may be configured to generate a sensor signal, for example, atissue thickness signal indicative of a thickness of the tissue (e.g.,for tissue located between the anvil and the staple cartridge of an endeffector portion of a surgical instrument). A controller may be insignal communication with the sensor. The controller may comprise ameans for identifying the staple cartridge type of the staple cartridge.The staple cartridge type and the thickness of the tissue may be used,for example, to determine if the thickness of the tissue located betweenthe anvil and the staple cartridge is within the optimal tissuethickness range of the staple cartridge.

In examples, a display or analysis (e.g., at a hub or remote server) may(e.g., interactively) combine sensed information with other information.For example, cartridge data may be interactively combined withinstrument actuator or configuration data, e.g., to provide a broaderunderstating of the (e.g., full; instrument status. Cartridge data cancorrespond to the size or type of staple being fired by the instrument,for example. Different types of staples may be utilized for differenttypes of tissues. Usage information (e.g., time from clamp to fire,characterization of user-controlled firing, etc.) may be displayedand/or processed, for example, in combination with sensed informationand/or other information.

At 11520, a determination may be made, based on the operation mode,whether to receive information (e.g., instrument usage instruction,operational information, and/or recommendations). For example, aprocessor (e.g., in a surgical instrument) may determine (e.g., based onan instrument operation mode), whether to receive information (e.g.,from hub 11006 or remote server 11013 via surgical hub 11006).

Information received may include, for example, identification of thetissue to be operated on or that is being operated on (e.g., based oninstrument or component position tracking information). See, forexample, FIG. 19 and accompanying discussion in U.S. patent applicationSer. No. 16/361,793, now U.S. Patent Application Publication No.2019/0314015, which shows multiple sensors that may be used in atracking system. A tracking procedure performed by the tracking systemmay be performed at a hub (e.g., surgical hub 11006). A processor in theinstrument may receive position information from a tracking procedure atthe hub.

Information received may include, for example, recommended usageinformation (e.g., time from clamp to fire, characterization ofuser-controlled firing, etc.). Information received may include, forexample, force-to-fire, wait time/period, speed, time from clamp tofire, etc. Information received may include, for example, informationfor display and/or information indicating whether to display on one ormore displays (e.g., a display on the handle of an instrument, a displayassociated with a hub or other display system), prioritization ofinformation to display, location (e.g., on one or more display screens)in which to display information, etc. Information received may includeinstructions determined based on, for example, sensed information, adisease state of the issue, previous firings of a surgical instrument ordevice (e.g., an endocutter) and associated sensed information, etc.Information received may include, for example, a cartridge selectionsequence; order.

Information received may include a recommendation to the surgeon, ifanother available stapler, another available energy device, and/oranother stapler component (e.g., staple cartridge, shaft, etc. availablefor use with the selected stapler/device) is more optimal or optionalInformation received may include a warning that a safety issue existswith the selected cartridge, or stapler/device. Examples ofrecommendations based on safety systems are described in detail in U.S.patent application Ser. No. 16/024,075, entitled “SAFETY SYSTEMS FORSMART POWERED SURGICAL STAPLING,” filed on Jun. 29, 2018, now U.S.Patent Application Publication No. 2019/0201146, which is herebyincorporated herein by reference in its entirety.

Information received may include, for example, situation awarenessinformation. The recommendation may be indicated with an elevatedpriority level based on an anticipated surgical act and the input fromthe situationally-aware surgical hub. For example, organ issue (e.g.,stomach, lung, and so on) may be identified based on sensed information.A determination may be made based on sensed information, such as textureand/or compressibility (e.g., stomach tissue is very thick and veryincompressible while lung tissue is very thick and very compressible). Aclamping operation recommendation (e.g., speed and timing) and a firingoperation recommendation (e.g., speed and timing such as a wait period)may be determined, for example, based on tissue identification.

Examples of recommendations based on situation awareness are presentedwith respect to FIGS. 9 and 10. FIG. 9 is a diagram of an examplesituationally aware surgical system. FIG. 10 illustrates an exampletimeline of an illustrative surgical procedure and the inferences thatthe surgical hub can make from the data detected at each step in thesurgical procedure. Other examples of recommendations based on situationawareness are disclosed in U.S. patent application Ser. No. 16/182,246,entitled “ADJUSTMENTS BASED ON AIRBORNE PARTICLE PROPERTIES,” filed onNov. 6, 2018, now U.S. Patent Application Publication No. 2019/0204201,which is hereby incorporated herein by reference in its entirety.

At 11530, communication may occur (e.g., via an instrument transmitter)with a surgical hub based on the determination at 11510 or 11520.Communications involving a surgical instrument (e.g., in second mode;tier operation) may include sending and/or receiving information (e.g.,as shown by example in FIG. 23) using, respectively, a transmitterand/or a receiver. In examples, an instrument processor may beconfigured to obtain and send a sensed parameter to a surgical hub, forexample, based on a determination that the instrument operation modesupports obtaining the sensed parameter. In examples, an instrumentprocessor may be configured to receive an instrument usage instructionfrom the surgical hub via a receiver, for example, based on adetermination that the instrument operation mode supports receiving theinstrument usage instruction. The instrument processor may send thereceived instrument usage instruction to a display. In examples, aninstrument processor may be configured to receive cartridge informationfrom an end effector. The instrument processor may determine, based onthe instrument operation mode, whether to combine the cartridgeinformation with an instrument usage parameter (e.g., a time from clampto fire and/or a characterization of a user-controlled firing) Theinstrument processor may, based on a determination that the instrumentoperation mode supports this capability, send the instrument usageparameter with the cartridge information to the surgical hub (e.g., viathe transmitter).

FIG. 24 illustrates an example surgical instrument operation mode. FIG.24 shows an example of a third mode of operation (e.g., tier III).Surgical instrument 11012 may, in an example of a third mode ofoperation, engage in bidirectional communication with surgical hub 11006and provide information to display 11025 (e.g., for display to a user).Surgical hub 11006 may communicate with remote server 11013. Remoteserver 11013 may communicate with storage 11022 storing aggregated data.Remote server 11013 may communicate with a user portal 11026.

A third mode of operation may build on (e.g., add capabilities orfunctionality to) first and second modes of operation described herein.In some examples, a third mode of operation may add cloud storage ofinstrument usage, user accessibility, data aggregation, analyses andrecommendations. For example, an instrument processor may be configuredto determine (e.g., based on a mode of operation) whether to sendinformation (e.g., instrument accessory information, such as cartridgedata) that may be interactively combined (e.g., by a remoter cloudserver) with instrument actuator or configuration data (e.g., foraggregation). Information that may be stored and aggregated (e.g., withinstrument usage information) may include, for example, one or more ofthe following doctor identification information, type of surgery, patentinformation, or disease state. An instrument processor may be configuredto send information to a hub and/or (e.g., directly) to a remote server.

An instrument processor may be configured to determine (e.g., based on amode of operation) whether to receive a recommendation (e.g., aninstrument usage recommendation and/or an accessory selectionrecommendation) based on stored information (e.g., aggregatedhistoric/typical instrument usage information). For example, arecommendation may be recommended instrument usage information (e.g.,stapler cartridge selection) generated based on aggregated historicalinstrument usage data. For example, a recommendation may be a staplercartridge selection recommendation generated based on aggregatedcartridge usage data associated with a procedural step (e.g., of usingan instrument).

Historical information stored, aggregated, analyzed and used forrecommendations may include, for example, information about previousprocedures, such as procedure types, tissues, tissue conditions,accessory (e.g., cartridge) types selected and order of use in surgicalinstrument (e.g., surgical stapler), and so on. In various examples,historical information may include one or more of the following:compiled recommendations from database analysis (e.g., based onaggregated data); surgeon identification information (e.g., Dr. X);procedure information (e.g., bariatric procedure type); surgeons usageinformation (e.g., trend, prediction, typical use), cartridge selectionsequencer order, and/or display utilization (e.g., on an instrumenthandle or on a hub display/display system).

A remote server may aggregate data from multiple surgeries and users(e.g., surgeons). A remote server may send aggregated data and/or usagerecommendations to a surgical instrument (e.g., directly or via a hub).A remote server may allow a user to review, aggregate, or use storeddata to provide insights for future uses of an instrument e.g., asurgical stapler).

A third mode/tier of instrument operation may provide a user (e.g., asurgeon) access to historical data (e.g., their own data). A surgeon maychange a procedure over time (e.g., change cartridge selection oftype(s), combination and sequence). A cartridge may be color coded, forexample, to indicate staple heights (e.g., gray, white, blue, green,gold, or gold, green and black). Different staple heights may be used tostaple tissue, for example, based on one or more variables, such as atype of tissue, a state of tissue, and/or a gap between tissue.

Cartridge selection and usage information associated with a surgeon maybe stored for future review. Cartridge selection and usage informationassociated with a surgeon may be aggregated (e.g., over time). Surgicalprocedure information may be correlated with post operative data, suchas post-operative leaks, secondary complications and/or reoperationinformation.

Data analytics may be retrieved and viewed, for example, at a userportal 11026. Information about data collection, data aggregation,surgical data analytics, and remote (e.g., cloud) server access to dataand recommendations are disclosed in U.S. patent application Ser. No.15/940,679, entitled “CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCALUSAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGER DATASET,” filed on Mar. 29, 2018, now U.S. Patent Application PublicationNo. 2019/0201144, which is hereby incorporated herein by reference inits entirety.

Remote (e.g., cloud) server 11013 may include an input/output interfaceconfigured for accessing data from a plurality of medical hubcommunication devices (e.g., including surgical hub 11006). A medicalhub may be communicatively coupled to at least one surgical instrument(e.g., surgical instrument 11012). Remote server 11013 may include aprocessor configured to receive instrument usage information associatedwith a medical procedure performed by a user (e.g., a surgeon). Theremote server processor may be configured to aggregate the receivedinstrument usage information with historic usage information associatedwith the user. The processor may be configured to send the aggregatedinstruction usage information, for example, to a data analytics server,to a hub (e.g., surgical hub 11006), etc.

A remote server processor (e.g., in remote server 11013) may beconfigured to correlate received instrument usage information to anoutcome of a medical procedure and/or to an instrument operation statusduring the medical procedure. The remote server processor may beconfigured to send the correlated information, for example, to a hub(e.g., surgical hub 11006 for display to a user before, during and/orafter a medical procedure using surgical instrument 11012). A remoteserver may send correlated information, for example, as a referencebefore, during a medical procedure, and/or as a post-operative reviewfollowing a medical procedure, etc.

A remote server processor (e.g., in remote server 11013) may beconfigured to determine a recommended instrument usage informationassociated with an upcoming (e.g., or ongoing) medical procedure basedon the correlated information. The remote server processor may beconfigured to send the recommended instrument usage information, forexample, to a hub (e.g., surgical hub 11006 for display to a user beforeor during a medical procedure using surgical instrument 11012).

1. A surgical instrument, comprising: a sensor configured to provide asensor signal according to a physiological parameter of a tissue; atransmitter; and a processor configured to: determine, based on aninstrument operation mode, whether to obtain a sensed parameterassociated with the sensor signal from the sensor; determine, based onthe instrument operation mode, whether to receive an instrument usageinstruction; and communicate with a surgical hub based on at least oneof the determinations via the transmitter.
 2. The surgical instrument ofclaim 1, wherein the processor is further configured to: based on adetermination that the instrument operation mode supports obtaining thesensed parameter, obtain and send the sensed parameter to the surgicalhub.
 3. The surgical instrument of claim 1, further comprising: areceiver, wherein the processor is further configured to: based on adetermination that the instrument operation mode supports receiving theinstrument usage instruction, receive the instrument usage instructionfrom the surgical hub via the receiver; and send the instrument usageinstruction to a display.
 4. The surgical instrument of claim 1, furthercomprising: a receiver; and an end effector for removably storing asurgical staple cartridge, wherein the processor is further configuredto: receive cartridge information from the end effector; determine,based on the instrument operation mode, whether to combine the cartridgeinformation with an instrument usage parameter, wherein the instrumentusage parameter comprises at least one of: a time from clamp to tire, ora characterization of a user-controlled firing; and based on adetermination to combine, send the instrument usage parameter with thecartridge information to the surgical hub via the transmitter.
 5. Thesurgical instrument of claim 1, wherein the processor is furtherconfigured to determine the instrument operation mode based on aninstrument operation control parameter, wherein the instrument operationcontrol parameter comprises at least one of: a system capacityparameter, a system condition parameter, a system authorizationparameter, a tiered communication mode indication received from the hub,or a tiered communication mode indication received from a remote server.6. The surgical instrument of claim 1, further comprising: a receiver;and an end effector for removably storing a surgical staple cartridge,wherein the processor is further configured to: obtain staple cartridgeinformation and instrument status information from the end effector; andsend the cartridge information and the instrument status information tothe surgical hub.
 7. The surgical instrument of claim 1, wherein theprocessor is further configured to: determine, based on the instrumentoperation mode, whether to receive recommended instrument usageinformation generated based on aggregated historical instrument usagedata, wherein the instrument usage information comprises a staplercartridge selection.
 8. The surgical instrument of claim 1, wherein theprocessor is further configured to: determine, based on the instrumentoperation mode, whether to receive a stapler cartridge selectionrecommendation generated based on aggregated cartridge usage dataassociated with a procedural step.
 9. A remote server, comprising: aninput/output interface configured for accessing data from a plurality ofmedical hub communication devices, each communicatively coupled to atleast one surgical instrument; and a processor configured to: receiveinstrument usage information associated with a medical procedureperformed by a surgeon; aggregate the received instrument usageinformation with historic instrument usage information associated withthe surgeon; and send the aggregated instruction usage information. 10.The remote server of claim 9, wherein the processor is furtherconfigured to: correlate the received instrument usage information to anoutcome of the medical procedure; and send the correlated information.11. The remote server of claim 10, wherein the processor is furtherconfigured to: determine a recommended instrument usage informationassociated with an upcoming medical procedure based on the correlatedinformation; and send the recommended instrument usage information. 12.A method, comprising: providing, from a sensor, a sensor signalaccording to a physiological parameter of a tissue; determining, basedon an instrument operation mode, whether to obtain a sensed parameterassociated with the sensor signal; determining, based on the instrumentoperation mode, whether to receive an instrument usage instruction; andcommunicating with a surgical hub based on the determination via atransmitter.
 13. The method of claim 12, further comprising: based on adetermination that the instrument operation mode supports obtaining thesensed parameter, obtaining and sending the sensed parameter to thesurgical hub.
 14. The method of claim 12, further comprising: based on adetermination that the instrument operation mode supports receiving theinstrument usage instruction, receiving the instrument usage instructionfrom the surgical hub via a receiver; and sending the instrument usageinstruction to a display.
 15. The method of claim 12, furthercomprising: receiving cartridge information from an end effector forremovably storing a surgical staple cartridge; determining, based on theinstrument operation mode, whether to combine the cartridge informationwith an instrument usage parameter, wherein the instrument usageparameter comprises at least one of: a time from clamp to fire, or acharacterization of a user-controlled firm; and based on a determinationto combine, sending the instrument usage parameter with the cartridgeinformation to the surgical hub via the transmitter.
 16. The method ofclaim 12, further comprising: determining the instrument operation modebased on an instrument operation control parameter, wherein theinstrument operation control parameter comprises at least one of: asystem capacity parameter, a system condition parameter, a systemauthorization parameter, a tiered communication mode indication receivedfrom the hub, or a tiered communication mode indication received from aremote server.
 17. The method of claim 12, further comprising: obtainingstaple cartridge information and instrument status information from anend effector for removably storing a surgical staple cartridge; andsending the cartridge information and the instrument status informationto the surgical hub.
 18. The method of claim 12, further comprising:determining, based on the instrument operation mode, whether to receiverecommended instrument usage information generated based on aggregatedhistorical instrument usage data, wherein the instrument usageinformation comprises a stapler cartridge selection.
 19. The method ofclaim 12, further comprising: determining, based on the instrumentoperation mode, whether to receive a stapler cartridge selectionrecommendation generated based on aggregated cartridge usage dataassociated with a procedural step.